FDA Adverse Event Reporting System (FAERS) Electronic Submissions:
To assist industry when making certain regulatory submissions in electronic format to the FDA’s Adverse Event Reporting System (FAERS) database for the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
Statement of Policy Intent: International Recognition of Medical Devices
The UK Medicines and Healthcare products Regulatory Agency (MHRA) aims to facilitate quicker and more efficient access to medical devices by leveraging the expertise and decision-making processes of international regulatory partners. This initiative will benefit patients by allowing the MHRA to recognize approvals from other regulatory bodies, while still retaining the authority to reject applications if the supporting evidence is deemed insufficient.
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA
Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA: The purpose of this guidance is to provide recommendations for abbreviated new drug applications (ANDAs) or Prior Approval Supplements (PAS) to holders of Type II active pharmaceutical ingredient (API) DMFs.
Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry
- Appropriate Matter for a Request for Reconsideration?
- Refuse-to-receive decision
- Tentative approval letter
US FDA Temporary Policies for Compounding Certain Parenteral Drug Products Guidance for Industry:
As of October 10, 2024, under section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)), HHS Secretary Becerra has declared public health emergencies (PHEs) in North Carolina, Florida, Georgia, Tennessee, and South Carolina due to the impacts of Hurricane Helene, as well as in Florida because of Hurricane Milton. In late September 2024, Hurricane Helene severely affected one of the largest manufacturers of specific intravenous and peritoneal dialysis solutions in the U.S. The FDA is collaborating with this manufacturer and alternative suppliers to enhance the supply and mitigate the risk of shortages of essential drug products.