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The passing of the CARES Act in 2020, built on the authorization given to FDA in 2012 by the Food and Drug Administration Safety and Innovation Act (FDASIA), to address the problem of drug supply disruptions and shortages. The agency released a draft guidance to assist stakeholders in developing a Risk Management Plan (RMP) for certain prescription drug products, APIs and supporting medical device products.

A framework developed for an RMP should be in line with ICH Q9, as per FDA most disruptions are the result of quality issues. Definitions of the different types of stakeholders, as well as steps that each should take to reduce risks of a disruption in the supply chain are articulated. RMP can serve as a safeguard, helping manufacturers prepare for and respond to hazards that could lead to drug supply disruptions and shortages.

The guidance points to publications where some stakeholders who proactively assessed risks, were able to predict and prevent supply disruptions that could potentially have led to a drug shortage. The FDA hypothesizes that an investment in an RMP can lead to a reduction in the financial burden associated with resolving a shortage and problems that may lead to a shortage.

In addition to guidance on how to develop, maintain and implement an RMP, the guidance document includes a four page appendix which addresses risk considerations for specific RMPs.

Do keep in mind, the CARES Act does require certain manufacturers to have a redundancy risk management plan, which must be communicated to the FDA. You can read further information on the FDA’s Urges Drug Manufacturers to Develop Risk Management Plans to Promote a Stronger, Resilient Drug Supply Chain website, as well as the Risk Management Plans to Mitigate the Potential for Drug Shortages draft guidance document. 

On 23 May 2022, the Federal Register included an announcement regarding new regulation requirements for medical gases.  The agency has been working with stakeholders and Congress over the past few years, gathering input to evaluate whether the medical gas industry would benefit from specifically tailored regulatory changes. Proposed changes address labeling requirements, cGMP requirement updates, safety reporting requirement amendments, and codification of the certification process for designated medical gases.

Guidance Documents of Interest

Bioavailability Studies Submitted in NDAs or INDs – General Considerations

This guidance provides recommendations to sponsors and applicants submitting bioavailability information for drug products in investigational new drug applications, new drug applications, and NDA supplements. This guidance contains recommendations on how to meet the BA requirements set forth in 21 CFR part 320 as they apply to dosage forms intended for oral administration.

Refuse to Accept Policy for 510(k)s

The purpose of this document is to explain the procedures and criteria FDA intends to use in assessing whether a premarket notification (510(k)) submission meets a minimum threshold of acceptability and should be accepted for substantive review.

Benefit-Risk Considerations for Product Quality Assessments

This guidance describes the benefit-risk principles applied by FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls information submitted for FDA assessment as part of original new drug applications, original biologics license applications, or supplements to such applications.

Providing Submissions in Electronic Format — Postmarketing Safety Reports

This guidance provides general information on the electronic submission of postmarketing safety reports

Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program

The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this draft guidance to describe its policy regarding FDA’s participation in the Voluntary Improvement Program (VIP).

Assessing User Fees Under the Generic Drug User Fee Amendments of 2017

This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

The purpose of this guidance is to help human prescription drug and biological product sponsors, application holders, and applicants minimize medication errors associated with their products.

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production – Level 2 revision

This guidance for industry provides the Agency’s current thinking on how to evaluate out-of- specification test results.

All Guidance Documents can be searched on the FDA’s website.

Federal Register

FR Vol 87 No 78 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 057


Virtual Public Workshop – Building Medical Device Supply Chain Resilience: A Healthcare and Public Health Ecosystem-Wide Collaboration

Date: June 7 – 9, 2022
Day1: Tue, Jun 7 1:00 PM – 4:00 PM ET
Day2: Wed, Jun 8 1:00 PM – 4:00 PM ET
Day3: Thu, Jun 9 1:00 PM – 4:00 PM ET

Regulatory Education for Industry (REdI) Annual Conference 2022

Date: June 6 – 10, 2022
Time: 8:30 AM – 4:50 PM ET
June 6-7: CDER Drugs track
June 8-9: CDRH Devices track
June 9-10: CBER Biologics track

FDA Websites of Interest

Product-Specific Guidances for Generic Drug Development

This batch of 37 PSGs includes:

  • 24 new and 13 revised PSGs
  • 14 PSGs for complex products (11 new and 3 revised PSGs); 9 of these for products with no approved ANDAs (8 new PSGs)
  • 26 PSGs for products with no approved ANDAs (18 non-complex and 8 complex products)
  • New PSGs for products used as treatments for diseases or conditions, some of which were supported by Generic Drug User Fee Amendments (GDUFA) science and research.

Voluntary Medical Device Manufacturing and Product Quality Pilot Program

FDA Seeks to Engage Stakeholders on Key Considerations for a Drug Quality Management Maturity Program

Resilient Supply Chain Program for Medical Devices

The Key Elements of Being “Recall-Ready”

Posted in Drug and Device Corner, Drugs, Medical Devices.