Reminder: We are now in the registration renewal period for both drug establishments and medical device facilities. Drug listing certifications must also be submitted between 1 October and 31 December annually. If you need assistance with the process, please contact Victoria Pankovich at EAS.
The U.S. recently suffered devastating hurricanes which affected the availability of certain intravenous and peritoneal dialysis solutions in the United States. As a result, the FDA has announced the availability of a guidance document detailing the Temporary Policies for Compounding Certain Parenteral Drug Products. The guidance offers information on the agency’s enforcement priorities for outsourcing facilities, state-licensed pharmacies, and federal facilities that are not registered with FDA as outsourcing facilities.
The FDA has finalized their guidance document “Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA | FDA” which explains the process under which a type II API DMF will undergo an early assessment (prior assessment), 6 months prior to an ANDA or PAS submission referencing the DMF. Recommendations for DMF holders are also included.
Highlighted Guidance Documents
The purpose of this guidance is to provide a framework for considering whether and what type of long-term neurologic, sensory and developmental evaluations could be useful to support a determination of safety of a drug, biological product, or device (referred to as ‘medical product’ in this guidance) for use in neonates, and if so, which domains of neurodevelopment may be most applicable.
Requests for Reconsideration at the Division Level Under GDUFA
This guidance provides recommendations on the procedures for applicants of ANDAs that wish to pursue a request for reconsideration within the review discipline at the division level or original signatory authority. This guidance reflects GDUFA III and clarifies what matters are appropriate for requests for reconsideration. This guidance finalizes the draft guidance for industry of the same title issued on January 11, 2024.
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment
FDA is issuing this guidance to provide clarification to industry and FDA staff of the Federal regulations that relate to diagnostic x-ray equipment. The FD&C Act defines diagnostic x-ray systems as both a medical device and an electronic product, therefore these systems are subject to the provisions of the FD&C Act that apply to both medical devices and to electronic products, and their implementing regulations. This guidance document only addresses the requirements that apply to diagnostic x-ray equipment under the electronic product provisions of the FD&C Act and the regulations implementing those provisions. These regulations pertain to the recordkeeping, reporting, manufacturing, importing, and installation of electronic products. It does not address requirements that may apply to diagnostic x-ray equipment as medical devices. This guidance supersedes FDA’s guidance entitled “Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment”.
This guidance provides information for sponsors, clinical investigators, institutional review boards, contract research organizations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs.
All Guidance Documents can be searched on the FDA’s website.
Meetings
Updates:Acceptable Intakes of NDSRIs & BE Assessment for Reformulated Drugs (Virtual is free)
Date: November 6 & 7
Time : 8:30am – 4:30pm EST
Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation
Date: November 7, 2024
Time: 1:00 PM – 2:30 PM ET
Informed Consent – More than Just Another Document to Sign?
Date: November 8, 2024
Time: 2:00 PM – 3:00 PM ET
Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies
Date: November 12, 2024
Time: 11:00 AM – 12:00 PM ET
Nonprescription Analgesic/Antipyretic Drug Development in Children 2 to Less Than 12 Years of Age – 11/15/2024
Date: November 15, 2024
Time: 9:00 AM – 4:00 PM ET
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms — Implementing the Final Guidance
Date: November 21, 2024
Time: 1:00 PM – 3:00 PM ET
Clinical Pharmacology Considerations for Novel Therapeutic Modalities
Date: December 4, 2024
Time: 1:00 PM – 3:00 PM ET
Patient-Focused Drug Development: Workshop to Discuss Methodologic and Other Challenges Related to Patient Experience Data
Date: December 13, 2024
Time: 10:00 AM – 5:00 PM ET
FDA Websites of Interest
- CDRH Proposed Guidances for Fiscal Year 2025 (FY2025)
- Safety and Performance Based Pathway
- Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data
- Reduced Medical Device User Fees: Small Business Determination (SBD) Program
- Comments may be submitted at any time to Draft Pharmaceutical Quality/Chemistry Manufacturing and Controls Data Elements and Terminologies
- Annual Forecast for Planned Monograph Activities
- FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
- FDA Reorganizes Animal Drug Evaluation Structure to Better Align Innovative Products, Generic Drugs
- FDA Issues Final Guidance on Tattoo Inks
- Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets
- Accelerating Rare disease Cures (ARC) Program
- Navigating the Transition to Low Global Warming Potential Propellants – The Center for Research on Complex Generics (CRCG)
- 7 Things to Know About Drug Shortage Management
Posted in Drug and Device Corner, Drugs, Medical Devices.