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August 12, 2022
Ahead of this year’s reauthorization of the Generic Drug User Fee Amendments (GDUFA) , FDA has established a docket to solicit comments on the content of Appendix A in the July 2018 guidance for...
August 2, 2022
Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug...
July 29, 2022
Today, FDA is announcing the availability of a level 2 guidance for industry titled, Changes to Disposable Manufacturing Materials: Questions and Answers. FDA receives questions about the limited...
July 25, 2022
July 2022 As part of FDA’s continued efforts to improve transparency and provide helpful information to regulated industry and the public, the agency is issuing two final guidances for generic drug...
June 27, 2022
Final Guidance June 2022 This guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a waiver of the requirements of section 745A(a) of...
June 27, 2022
On June 23, 2022, The FDA issued the final version of its Guidance for Industry titled “Assessing the Effects of Food on Drugs in INDs and NDAs - Clinical Pharmacology Considerations”. The most...
June 8, 2022
Today, FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product Submitted in a Pre-ANDA Communication or an ANDA (5223.6).”...
April 27, 2022
GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...
February 12, 2021
How GDUFA II Impacts the Timing and Approval Process for Generic Drug Sponsors: Facing several regulatory challenges related to the review of abbreviated new drug applications (ANDAs), Congress first...