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FDA’s Darby Kozak provided commentary on the anniversary of the Drug Price Competition and Patent Term Restoration Act of 1984.

Hatch-Waxman Amendments Turn 40

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.

FDA Publishes New Product-Specific Guidelines for Generic Drug Development

In terms of extensions, the committee recommended Adcirca, Dupixent, Edistride, Enhertu, Fintepla, Forxiga, Hemlibra, Imfinzi (including two new indications), Kerendia, Spikevax and Triumeq.

EMA Recommends Five Medicines for Approval

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies. 

Generic-Drug Makers Also Fight Price Controls

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Best practices help mitigate generic drug shortages.

Meeting Supply and Training Challenges 

Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

FDA Approves Amneal’s Generic Version of TobraDex

Specialty pharmaceutical company, Advanz Pharma, has launched a generic version of lanreotide, MYTOLAC, in Germany.

Advanz Pharma Launches Generic Lanreotide in Germany

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

FDA and Industry Move to Renew New Drug User Fee Programs

Jennifer Markarian is a contributing editor for 

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing. 

Generic Drugs