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Sue Sutter

Senior Editor

Washington, D.C.
Sue is a senior editor with Pink Sheet, where she writes primarily about drug, biologic and biosimilar regulation, FDA advisory committees and product approvals.  She has reported on the prescription and over-the-counter drug industries since 1999 for various publications now under the umbrella of Informa Business Information, including Pink Sheet, “The Pink Sheet” DAILY, “The Tan Sheet” and Scrip.  Previously she worked as an editor for Mealey’s Litigation Reports (now part of Lexis-Nexis), writing about asbestos, toxic tort and fen-phen litigation.

Latest From Sue Sutter

FDA Expedites ANDA Postapproval Manufacturing Changes

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

User Fees Generic Drugs

Coronavirus Notebook: Fauci Calls For Restraint In Disclosing Early Data; Bipartisan Lawmakers Want Warp Speed Audit

Dispatches from a world turned upside down also include the conditional approval of remdesivir in South Korea.

Coronavirus COVID-19 Research & Development

COVID-19 Vaccines: EUA Route Offers Advantage In Review Speed, Not Level Of Evidence

US FDA’s ‘may be effective’ standard for granting an emergency use authorization is expected to be comparable to the substantial evidence of effectiveness needed to support full licensure of a COVID-19 vaccine, although EUA allows for a more rapid review, agency officials say.

Coronavirus COVID-19 Vaccines

Excipients Group Seeks Seat At GDUFA Negotiating Table

IPEC-Americas requests an improved communications channel with the FDA and formal inclusion in talks to reauthorize the generic drug user fee program; agency says industry negotiators generally represent product manufacturers and API suppliers that are subject to user fees.

Generic Drugs User Fees

US FDA Expediting ANDA Postapproval Manufacturing Changes Due To COVID-19 Impacts

Generic drugs program has approved almost 300 manufacturing changes to help shore up the supply chain, with some prior approval supplements being downgraded to ‘changes being effected’ supplements, FDA officials said at GDUFA III kick-off meeting.

Generic Drugs User Fees

GDUFA III: Excipients Group Seeks Seat At Negotiating Table, But US FDA Skeptical

IPEC-Americas requests an improved communications channel with the FDA and formal inclusion in talks to reauthorize the generic drug user fee program; agency says industry negotiators generally represent product manufacturers and API suppliers that are subject to user fees.

Generic Drugs User Fees
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