REMINDER CARES Act Drug Shortage Mitigation Efforts reporting deadlines
- Reports for calendar year 2020 should be submitted no later than 15 February 2022
- Reports for calendar year 2021 should be submitted no later than 16 May 2022
Cover Letter Attachments for Controlled Correspondences and ANDA Submissions
The FDA has created check lists to be used, at applicant’s discretion, to assist in creating cover letters for Controlled Correspondence, and Abbreviated New Drug Application submissions. The point of these check lists, which would be included in addition to the cover letter not in lieu of, is to assist the agency in effectively triaging and managing submissions. The agency’s hope is that these attachments will improve performance review goal date achievement by streamlining the process. The guidance document includes the check list templates in appendixes 1-3.
Guidance Documents of interest
The agency has offered further guidance regarding the Control of Nitrosamine Impurities in Human Drugs Guidance Document issued in September of 2020. See the Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products website for full details.
FDA is issuing this guidance as part of its RWE Program to satisfy, in part, the mandate under section 505F of the FD&C Act to issue guidance about the use of RWE to help support approval of a new indication for a drug already approved under section 505(c) of the FD&C Act or to help support post-approval study requirements.
For the purposes of this guidance, FDA defines real-world data (RWD) and RWE as follows:
- RWD are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
- RWE is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD.
This guidance provides sponsors and other stakeholders with considerations when either proposing to design a registry or using an existing registry to support regulatory decision-making about a drug’s effectiveness or safety. This guidance does not provide recommendations on choice of study design or type of statistical analysis when analyzing data from registries (registry data).
FDA is issuing this guidance as part of its RWE Program and to satisfy, in part, the mandate under section 505F of the FD&C Act to issue guidance on the use of RWE in regulatory decision-making. For the purposes of this guidance, FDA defines real-world data (RWD) and RWE as follows:
- RWD are data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.
- RWE is the clinical evidence about the usage and the potential benefits or risks of a medical product derived from analysis of RWD.
Inspection of Injectable Products for Visible Particulates
This guidance addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inspection techniques, particulate identification, investigation, and corrective actions designed to assess, correct, and prevent the risk of visible particulate contamination. The guidance also clarifies that meeting an applicable United States Pharmacopeia (USP) compendial standard alone is not generally sufficient for meeting the current good manufacturing practice (cGMP) requirements for the manufacture of injectable products.
The U.S. Food and Drug Administration recommends the consistent use of terms and definitions of legal significance. In light of recent amendments to section 201(h) of the FD&C Act as a result of the enactment of the Safeguarding Therapeutics Act, FDA is issuing this draft guidance to promote clarity regarding references to the terms “device” and “counterfeit device.”
Q3C(R8) Impurities: Guidance for Residual Solvents
This guidance provides recommendations for permitted daily exposures for three additional residual solvents:
(1) 2-methyltetrahydrofuran,
(2) cyclopentyl methyl ether, and
(3) tert-butyl alcohol.
This guidance is intended to recommend acceptable amounts for these residual solvents in pharmaceuticals for the safety of the patient. As part of the maintenance process for the ICH guidance for industry Q3C Impurities: Residual Solvents (December 1997), the Q3C PDE levels are added and revised as new toxicological data for solvents become available.
This guidance provides recommendations to holders of biologics license applications for specified biological products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12. Specifically, the guidance describes CMC post-approval manufacturing changes that FDA generally considers to have a minimal potential to have an adverse effect on product quality.
All Guidance Documents can be searched on the FDA’s website.
Federal Register notices
FR Vol. 79, No. 25 Study Data Technical Conformance Guide and Data Standards Catalog; Availability
FR Vol. 86, No. 234 Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 056
FDA websites of interest
Tracking Your Premarket Submission’s Progress (Progress Tracker)
The FDA offers online progress tracking to fulfill its Medical Device User Fee Act (MDUFA) commitments.
Generic Drug Research Priorities & Projects FY2022 GDUFA Science and Research Priorities have been announced.
OTC Monographs@FDA reports the FDA’s progress on proposed, final, and interim final orders for OTC monograph drugs.
Posted in Drug and Device Corner, Drugs, Medical Devices.