expanded access - Schulman IRB

Webinar Series

Expanded Access/Compassionate Use Part 2

Drugs for Larger Patient Populations and Devices October 28, 2015 Presented by: Rebecca Carson Rogers, MA, CIP, CHRC IRB Chair, Schulman IRB

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Webinar Series

About Today’s Presenter Rebecca Carson Rogers, MA, CIP, CHRC IRB Chair, Schulman IRB  IRB Chair at Schulman IRB since 2014  Previously served as Assistant Director of Dartmouth College’s IRB and as IRB Member  Also previously served as Research Regulatory and Compliance Officer at Dartmouth Cancer Center  Contributor to 1st and 2nd editions of Bankert and Amdur’s IRB: Management and Function  Experienced educator and presenter on human subject protection topics

Objectives  Identify requirements for expanded access of investigational drugs and biologics for intermediate and large patient populations, including: • • • •

FDA role Drug company role Investigator role IRB review requirements

 Describe FDA mechanisms for early/expanded access of devices • Define FDA, manufacturer, sponsor, investigator and IRB roles for expanded access for devices

 Explain possible patient charges for expanded access use of drugs and devices  Consider expanded access scenarios

FDA Expanded Access for Investigational Drugs

Wherever possible, use of an investigational medical product by a patient as part of a clinical trial is preferable. Clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. FDA News/Event Public Health Focus Expanded Access Compassionate Use webpage http://www.fda.gov/NewsEvents/PublicHealthFocus/Expanded AccessCompassionateUse/default.htm

Expanded Access vs Use in a Clinical Trial  Expanded access is the use outside of a clinical trial of an investigational medical product that has not been approved by FDA.  Expanded access uses are not primarily intended to obtain information/data about the safety or effectiveness of a drug.  The terms compassionate use, expanded access, access, and treatment use are used interchangeably to refer to use of an investigational product when the primary purpose is to diagnose, monitor, or treat a patient’s disease or condition.

FDA Commitment to Expanded Access for Investigational Drugs and Devices

FDA is committed to increasing awareness of and knowledge about its expanded access programs and the procedures for obtaining access to human investigational drugs (including biologics) and medical devices. Is access guaranteed?

Can FDA Require a Company to Provide Expanded Access to Its Investigational Product?

NO. • FDA cannot compel a company to provide expanded access to its investigational product. • When a company provides expanded access to its product, it is doing so voluntarily.

How Does the Product Get to the Individual Patient?

Regardless of who is the sponsor of any access protocol or access IND: • The patient can obtain access to the investigational product only through a licensed physician. 21 CFR 312.310

Expanded Access to Investigational Drugs for Treatment Use

Categories

Under FDA’s current regulations, there are three categories of expanded access to Investigational Drugs for Treatment Use: • Expanded access for individual patients, including for emergency use 21 CFR 312.310 • Expanded access for intermediate-size patient populations 21 CFR 312.315 • Expanded access for large patient populations under a treatment IND or treatment protocol 21 CFR 312.320

Access: Two Processes 1. Access IND: a new IND submission, which is separate and

distinct from any existing INDs and is intended only to make a drug available for treatment use. 21 CFR 312.305(b)(1)

 An access IND submission generally should be used when: (1) there is no existing IND in effect for the drug, OR (2) there is an existing IND in effect for the drug, but the sponsor of the existing IND declines to be the sponsor of the access use  Example: for an individual patient use or an intermediate-size patient population use, the sponsor of the existing IND may prefer that the patients’ physician submit an individual patient or intermediate-size patient population IND.

Access: Two Processes 2. Access protocol: Sponsor/IND holder submits as a protocol amendment to an existing IND.  When there is an existing IND in effect, FDA generally encourages the submission of an access protocol, rather than a new access IND: • Having all access and clinical trial use consolidated under a single IND may facilitate earlier detection of safety concerns associated with a drug. • The administrative process is less burdensome for sponsors and FDA.

Intermediate-Size Patient Populations Multiple patients with the same condition Consolidate access in an intermediate size patient population IND 21 CFR 312.315

What does “intermediate-size” mean? The number of patients who will receive access to the investigational drug is: Smaller than the large populations typical of treatment INDs (hundreds to thousands of patients) AND Larger than one patient

Intermediate-Size Patient Population Access vs Treatment IND or Protocol

Intermediate-size patient population access programs: • Used earlier in drug development than treatment INDs or protocols. • Can be used to obtain access to: – A drug that is not being developed 21 CFR 312.315(a)(1) – An approved or related drug that is not available through marketing channels 21 CFR 312.315(a)(3)

Physician Submission of Intermediate-Size Patient Population Access IND  Start with the drug company that has an IND for the investigational drug. • When a licensed physician would like to obtain an investigational drug for their patients, he/she should first ensure that the manufacturer is willing to provide the investigational drug. • If the manufacturer agrees, they should provide the physician with a letter of authorization (LOA) that permits FDA to refer to IND submission information the manufacturer has submitted to FDA. • The physician should then submit an intermediate-size patient population expanded access IND application to FDA using FDA Form 1571.

Physician Becomes Sponsor-Investigator

The physician is considered a sponsor-investigator and is responsible for complying with the responsibilities for sponsors and investigators, including: • submitting IND safety reports, • submitting annual reports, AND • maintaining adequate drug disposition records

Sponsor Submission of Intermediate and Large Size Population Patient Access IND or Protocol

The sponsor of the existing IND can submit an intermediate or large size patient population access IND or protocol and cross-reference information in its existing IND to support the access IND. • The sponsor of the existing IND is also the sponsor of the access IND. • The patient’s physician is the investigator for the access IND.

FDA Criteria for Granting Intermediate-Size Population Expanded Access  The potential benefit justifies the potential risks of the treatment use with the drug. • AND those risks are not unreasonable in the context of the disease or condition to be treated.  The patients have a serious or life-threatening disease or condition.  There are no other comparable or satisfactory therapeutic options.  Providing access will not interfere with development of the drug.  Patient cannot obtain the drug under another IND or protocol (such as clinical study of the drug).

FDA Criteria to Authorize Expanded Access  To authorize any category of expanded access, FDA must determine that access to the drug for the requested use will not: • Interfere with the initiation, conduct, or completion of clinical investigations that could support marketing approval of the expanded access use. • Otherwise compromise the potential development of the drug for the expanded access use. 21 CFR 312.305(a)(3)

 Expanded access programs that treat larger patient populations generally have the greatest potential for interfering with clinical investigations or drug development.

FDA Criteria to Authorize Expanded Access  Potential concerns: • Interference with recruiting patients for ongoing clinical trials. • Impact on supply of the investigational drug.  Safeguards: • Sponsor submission of an investigational plan with a timetable and milestones. • FDA periodic assessment of the expanded access affect on accrual of patients in the clinical trials or other parameters related to the pace of product development.  If FDA determines that the ongoing expanded access is interfering with clinical trials or drug development, or that the sponsor is not pursuing marketing approval for the expanded access use with due diligence, FDA could place the treatment IND or IDE on clinical hold. 21 CFR 312.42(b)(3)

Large Patient Populations – Treatment IND or Protocol Broad access to an investigational drug in the later stages of development. Does NOT include a planned, systematic data collection and a design to meaningfully evaluate a safety issue. Often a method of access during the time between completion of clinical trials and FDA approval of the drug. 21 CFR 312.320

FDA Criteria for Granting Large-Size Population Expanded Access – Treatment Use  Drug is being investigated in a clinical trial under an IND designed to support a marketing application for the expanded access use. OR  All clinical trials of the drug have been completed. AND  Sponsor is actively pursuing marketing approval of the drug for the expanded access use. AND  There is sufficient evidence.

FDA Criteria for Granting Large-Size Population Expanded Access – Treatment Use Evidence is usually data from phase 3 trials, but could consist of compelling data from completed phase 2 trials.  For expanded access to treat for an immediately lifethreatening disease or condition, FDA approval could be based on more preliminary clinical evidence.  The sponsor is responsible for monitoring the treatment protocol to ensure that treating physicians comply with the protocol and applicable regulations.

IRB and Informed Consent Requirements for Intermediate and Large Population Expanded Access

 IRB requirements apply. 21 CFR part 56 • IRB approval must be obtained before starting treatment under an expanded access IND unless it is for emergency use. • IRB must review the expanded access use at a convened (full Board) meeting.

 Informed consent requirements apply to treatment provided to patients under expanded access INDs and protocols. 21 CFR part 50 • Informed consent must be obtained before initiating treatment, including in the case of emergency use, unless one of the exceptions found in part 50 applies.

IRB Review – Submission Requirements  Treatment protocol to be executed  Informed consent document  Written proof that submitting practitioner/investigator or sponsor has sent documents to FDA for expanded access IND approval  Form 1571 signed by submitting practitioner/investigator or sponsor  IB and safety reports for drug

IRB Review – Submission Requirements (cont’d)  Practitioner must be familiar with “information on the drug’s safety and effectiveness derived from previous clinical and nonclinical experience with the drug” 21 CFR 312.35 (b)(1)(vi) • Submit signed and dated statement from treating practitioner confirming that he/she reviewed the currently available product information and understands the information contained therein

 Appropriate IRB submission forms  CV and license of submitting practitioner/investigator

Treating Under Access INDs and Protocols NOT for Emergency Use

When can treatment begin under access INDs not for emergency use? • All expanded access INDs go into effect 30 days after FDA receives the IND or on earlier notification by FDA. • The treatment use of the drug may begin when the IND goes into effect and IRB approval has been obtained.

Treating Under Access INDs and Protocols NOT for Emergency Use

When can treatment begin under access protocols not for emergency use? • Access to drug can begin once an access protocol has been submitted to FDA and has been approved by an IRB.

What Is the Scope of “Access”?

Patient access, both dosage and duration, is limited to the description in the FDA and IRB approved treatment protocol. Access is NOT at the discretion of the treating physician. • Unless this is specified in the treatment protocol.

Case Study Physician learns of an investigational product under development as a treatment for a condition she treats. She has three drug refractory patients with this condition who are not eligible for the open clinical trials. What is the best way for her to start the process of obtaining the investigational product for her patients? 1) 2)

3) 4)

Determine which IRB she needs to use to review her plan to treat her patients with the investigational product. Begin to complete the FDA Form 1571 in order to obtain individual patient access INDs. Contact the drug sponsor to inquire about obtaining the investigational drug. Begin to complete the FDA Form 1571 in order to obtain an intermediate size population patient access IND.

Case Study Physician learns of an investigational product under development as a treatment for a condition she treats. She has three drug refractory patients with this condition who are not eligible for the open clinical trials. What is the best way for her to start the process of obtaining the investigational product for her patients? 1) 2)

3) 4)

Determine which IRB she needs to use to review her plan to treat her patients with the investigational product. Begin to complete the FDA Form 1571 in order to obtain individual patient access INDs. Contact the drug sponsor to inquire about obtaining the investigational drug. Begin to complete the FDA Form 1571 in order to obtain an intermediate size population patient access IND.

Case Study Physician reads that an antibiotic used many years ago that is no longer FDA approved may be beneficial in circumstances that seem similar to a few patients she is treating for antibiotic resistant infections. Is there any chance she will be able to obtain this drug for her patients?

1) 2)

3) 4)

No, since the drug is no longer FDA approved, it is not available in the US. Yes, she needs to contact the drug manufacturer to learn if there is a source of the drug. No, even if the manufacturer still has an unexpired source of the drug, FDA will not allow access. Yes, she needs to contact the FDA to learn if there is an existing access protocol.

Case Study Physician reads that an antibiotic used many years ago that is no longer FDA approved may be beneficial in circumstances that seem similar to a few patients she is treating for antibiotic resistant infections. Is there any chance she will be able to obtain this drug for her patients?

1) 2)

3) 4)

No, since the drug is no longer FDA approved, it is not available in the US. Yes, she needs to contact the drug manufacturer to learn if there is a source of the drug. No, even if the manufacturer still has an unexpired source of the drug, FDA will not allow access. Yes, she needs to contact the FDA to learn if there is an existing access protocol.

Early/Expanded Access to Investigational Devices for Treatment Use

Early/Expanded Access to Investigational Devices for Treatment Use NOTE: Humanitarian Use Devices are NOT considered investigational devices by the FDA. Consult FDA Guidance regarding use of an HUD outside its approved indications in an emergency or when there is no alternative device for the patient’s condition.

IDE Early/Expanded Access  An unapproved medical device may normally only be used on human subjects through an approved clinical study in which the subjects meet certain criteria and the device is only used in accordance with the approved protocol by a clinical investigator participating in the clinical trial.  However, there may be circumstances under which a health care provider may wish to use an unapproved device to: • Save the life of a patient. • Help a patient suffering from a serious disease or condition for which there no other alternative therapy exists. http://www.fda.gov/MedicalDevices/DeviceRegul ationandGuidance/HowtoMarketYourDevice/Inves tigationalDeviceExemptionIDE/ucm051345.htm

IDE Early/Expanded Access

FDA may make an unapproved device available through the following:  Emergency Use  Emergency Research 21 CFR 50.24  Compassionate Use (or Single Patient/Small Group Access)  Treatment Use  Continued Access

Device Expanded Access Early/ Expanded Access

Continued Access Treatment Use

Traditional IDE Study

Emergency/Compassionate Use Before IDE

IDE Approval

IDE Completion

Marketing Approval

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Howto MarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm

Emergency Use Timeframe: Before or after initiation of the clinical trial  When can a device be used in an emergency situation? • There is no Investigational Device Exemption (IDE), or before an IDE is approved. • Physician wants to use the device in a way not approved under an existing IDE. • A physician is not part of the IDE study.

 Criteria: • Life-threatening or serious disease or condition. • No alternative. • No time to obtain FDA approval.

Emergency Use  Physician’s responsibilities • The physician has his/her evaluation of the patient situation reviewed and evaluated in writing by an uninvolved physician.

 Report to IRB within 5 working days after the emergency use.  If an IDE exists, notify the sponsor. The sponsor must report to FDA within 5 days  If an IDE does not exist, notify FDA of the emergency use and provide FDA a written summary of the emergency use.  Evaluate the likelihood of a similar need for the device. • If similar need is likely, obtain an IDE from FDA for future use and IRB approval.

Compassionate Use (Single Patient/Small Group Access) Timeframe: During clinical trial  FDA recognizes that there are circumstances in which an investigational device is the only option available for a patient faced with a serious, albeit not life-threatening, disease or condition.  This provision is typically approved for individual patients but may be approved to treat a small group.

 Criteria: • Serious disease or condition. • No alternative.

Compassionate Use  Prior FDA approval is needed before compassionate use occurs. • To obtain Agency approval, the sponsor should submit an IDE supplement requesting approval for a compassionate use under section §812.35(a) in order to treat the patient.

 Sponsor and treating physician work together to provide FDA: • Description of the patient's condition • Why alternatives therapies are unsatisfactory • Why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition • Identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient(s)

Compassionate Use

Patient protection measures that will be followed: • • • • •

Informed consent Concurrence of IRB chairperson Clearance from the institution Independent assessment from uninvolved physician Authorization from IDE sponsor

Compassionate Use FDA considerations:  Specific information about the patient or group of patients involved  Whether preliminary evidence of safety and effectiveness justifies compassionate use  Whether compassionate use would interfere with the conduct of a clinical trial to support marketing approval

When FDA approved:  Patient monitoring plan •

Treating physician develops an appropriate schedule for monitoring the patient to detect any possible problems arising from the use of the device.

 Follow-up report •

Following the compassionate use of the device, a follow-up IDE report is submitted including information regarding patient outcome.

 If any problems occurred as a result of device use, these should be reported to the reviewing IRB as soon as possible and included in the IDE report.

Compassionate Use – IRB Review  Compassionate use requires prior FDA and IRB concurrence.  IRB requirements apply. 21 CFR part 56 • IRB approval must be obtained before starting treatment under an expanded access IDE unless it is for emergency use.  Informed consent requirements apply to treatment provided to patients under expanded access IDEs. 21 CFR part 50 • Informed consent must be obtained before initiating treatment, including in the case of emergency use, unless one of the exceptions found in part 50 applies.

Treatment Use Timeframe: During clinical trial or prior to final action on the marketing application  An approved research IDE specifies the maximum number of clinical sites and the maximum number of human subjects that may be enrolled in the study. • During the course of the clinical trial, if the data suggests that the device is effective, then the trial may be expanded to include additional patients with life-threatening or serious diseases.

 Criteria: • • • •

Life-threatening or serious disease No alternative Controlled clinical trial ongoing or completed Sponsor pursuing marketing approval

Continued Access or Extended Investigation Timeframe: After clinical trials and prior to final action on the marketing application  To allow access to the investigational medical device while the marketing application is being prepared by the sponsor or reviewed by FDA.  Also called an extended investigation.  Allows the collection of additional safety and effectiveness data to support the marketing application or to address new questions regarding the investigational device.  Criteria: • Public health need • Preliminary evidence that the device will be effective and there are no significant safety concerns

Treatment Use and Continued Access  Applications are made by the sponsor/IDE holder.  When can the treatment or continued access use of the device begin? • Treatment use may begin 30 days after FDA receives the treatment or continued access IDE submission and IRB approval obtained. • FDA may notify the sponsor in writing earlier than the 30 days that the treatment use may or may not begin.

Treatment Use and Continued Access – IRB requirements  Treatment Use and Continued Access require prior FDA and IRB approval.  IRB requirements apply. 21 CFR part 56 • IRB approval must be obtained before starting treatment under an expanded access IDE unless it is for emergency use. • IRB must review the expanded access use at a convened (full Board) meeting.

 Informed consent requirements apply to treatment provided to patients under expanded access IDEs. 21 CFR part 50 • Informed consent must be obtained before initiating treatment, including in the case of emergency use, unless one of the exceptions found in part 50 applies.

Reporting Requirements  Until the filing of a marketing application: • Sponsor must submit progress reports on a semi-annual basis to all reviewing IRB's and FDA.

 After filing of a marketing application: • Progress reports must be submitted annually in accordance with the IDE regulations.

 The sponsor of a treatment use or expanded access IDE is responsible for submitting all other reports required under §812.150 (Reports), such as unanticipated adverse device effects and final reports.

Case Study During surgery the surgeon determines that the stent she planned to use will not work for this patient. She knows an investigational stent is available because her colleague is the PI on a clinical trial. With no time to waste, due to the patient’s deteriorating condition, she implants the investigational stent. Which of the following are true? 1) 2)

3) 4)

Since the patient was not enrolled in the investigational stent trial, the surgeon should not have used this stent. Since this was an emergency, the use of the investigational stent is permitted by regulation. Licensed physicians may use devices off label. Since the patient is not enrolled in the stent clinical trial, there is no need to report patient information to the sponsor.

Case Study During surgery the surgeon determines that the stent she planned to use will not work for this patient. She knows an investigational stent is available because her colleague is the PI on a clinical trial. With no time to waste, due to the patient’s deteriorating condition, she implants the investigational stent. Which of the following are true? 1) 2)

3) 4)

Since the patient was not enrolled in the investigational stent trial, the surgeon should not have used this stent. Since this was an emergency, the use of the investigational stent is permitted by regulation. Licensed physicians may use devices off label. Since the patient is not enrolled in the stent clinical trial, there is no need to report patient information to the sponsor.

Case Study A couple of patients connect online, realize they are using the same specialist for their condition, and determine that a device approved in Germany will provide significant therapeutic effect for them. They call the specialist and ask if he can obtain this device to treat them. Which of the statements below are accurate?

1) 2)

3) 4)

Devices not approved for use in the US are not available for US physicians to use. This device may be able to be used under compassionate use access if it has an IDE in the US. FDA may approve devices for compassionate use prior to an IDE being approved. The device may not be used because this is not emergency use.

Case Study A couple of patients connect online, realize they are using the same specialist for their condition, and determine that a device approved in Germany will provide significant therapeutic effect for them. They call the specialist and ask if he can obtain this device to treat them. Which of the statements below are accurate? 1) 2)

3) 4)

Devices not approved for use in the US are not available for US physicians to use. This device may be able to be used under compassionate use access if it has an IDE in the US. FDA may approve devices for compassionate use prior to an IDE being approved. The device may not be used because this is not emergency use.

Charging Patients for Expanded Access to Investigational Products

Charging for Expanded Access Use of Drugs In some cases, patients may have to pay for using the investigational drug and/or for medical care associated with the use of the investigational drug.

Sponsor may charge for:  Individual patient expanded access • Direct costs associated with making the drug available to the patient. 21 CFR 312.8(d)

 Intermediate-size patient population expanded access program or a treatment IND or protocol • Direct drug costs AND the cost of monitoring the access IND or protocol, complying with IND reporting requirements, and other administrative costs directly associated with the expanded access use. 21 CFR 312.8(d)(2)

Charging for Expanded Access Use of Drugs Site charges:  Costs incurred at the expanded access site are not within the scope of the FDA regulations. FDA authorization is not needed to recover those costs.  Examples: • • • •

Pharmacy costs Nursing costs Equipment costs Costs for study-related procedures

 Charging for expanded access to an investigational drug may continue for one year from the time of FDA authorization, unless FDA specifies a shorter period. 21 CFR 312.8(d)(4)

Charging for Expanded Access Use of Devices The Investigational Device Exemption (IDE) regulations allow sponsors to charge for an investigational device.  Charge should not exceed cost recovery of manufacture, research, development, and handling of the investigational device. 21 CFR 812.7(b)  Sponsor justifies the proposed charges for the device in the IDE application, states the amount to be charged, and explains why the charge does not constitute commercialization. 21 CFR 812.20(b)(8)

FDA generally allows sponsors to charge investigators for investigational devices, and this cost usually is passed on to the subjects.

IRB Concerns Regarding Charging for Expanded Access Use From Dartmouth Committee for the Protection of Human Subjects (CPHS) SOPs:

Costs for Expanded Access Use. Under certain conditions, in general the FDA permits sponsors to charge for its direct costs of a drug, agent, or biologic that is approved for expanded access use. 21 CFR 312.8

The CPHS pays particular attention to issues of equity when considering the situation in which a patient is responsible for some costs of the drug or biologic. Expanded access use may preclude economically disadvantaged individuals as a class from access to test agents. The CPHS balances this potential lack of access against the possibility that the drug or biologic may not be available as therapy until it receives FDA approval when similar access barriers could exist.

In Conclusion – Key Points  When access to an investigational medical product by a patient is being considered, start by determining patient’s eligibility for an ongoing clinical trial.  Patients may have access to investigational or unapproved drugs and devices through FDA early access or expanded access programs.  Emergency use access does not require prior IRB approval. Reporting to the responsible IRB within 5 days of use is required.

In Conclusion

Consider the expanded access scenarios you are most likely to encounter and

be prepared.

 Know your institution’s/organization’s policy on expanded access and emergency use, including: • Cost coverage • Is an individual physician permitted to be an IND/IDE holder sponsor/investigator? • IRB requirements • Pharmacy and device storage policies

FDA Resources on Expanded Access  Form FDA 1571 This is the currently approved application form for submitting requests for an expanded access INDs for investigational drugs, including biologics.  FDA Draft Guidance: Expanded Access to Investigational Drugs for Treatment Use – Qs (PDF)  FDA Draft Guidance: Charging for Investigational Drugs Under an IND – Qs (PDF) FDA’s current expanded access regulations for investigational drugs (including biologics).  21 CFR 312 Subpart I Learn more about FDA’s current expanded access regulations for investigational drugs (including biologics).  Expanded Access Information for Medical Devices Learn more about IDEs and the expanded access requirements for medical devices.  Expanded Access INDs and Protocols 2009 – 2014 Data on FDA's Expanded Access performance.  Charging for Investigational Drugs Under an IND – Qs and As

Webinar Series

Expanded Access/Compassionate Use Part 2

Drugs for Larger Patient Populations and Devices October 28, 2015 Presented by: Rebecca Carson Rogers, MA, CIP, CHRC IRB Chair, Schulman IRB