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Tracy Beth Høeg Named Acting Director Of US FDA Drug Center

In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.

Only One ANDA Was Submitted To The US FDA During The Shutdown; It Should Have Been None

The FDA said an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

The Talk Of The Town: Biosimilars Developers React To FDA Streamlining

In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.

Lupin Signs A Deal With Valorum For Its First Approved Biosimilar Pegfilgrastim

Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.

In Latest US FDA Drug Center Change, Lead In OTC Monograph, Switch Program Overhauls Out

FDA says Teresa Michele, in CDER nonprescription drugs program leadership roles since 2013, was being moved to another position in the agency.

In Challenge To Age-Restricted Sales, CRN Argues Court ‘Diluted Constitutional Protections’

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.

Obscure User Fee Provision Gives Generic Drug Sponsors More Time To Pay Fees Post-Shutdown

ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.

FDA Approval Sets Stage For Accord’s 2026 Denosumab Biosimilars Rollout

FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.

Amneal Scores Dual FDA Wins In High-Value Complex Generics

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires

Pazdur’s departure just weeks into the job creates more uncertainty for the biopharma industry and an embarrassing situation for Commissioner Martin Makary, who personally lobbied him to take the position.

GDUFA IV: US FDA Wants to ‘Streamline’ Formal Meeting Structure

The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.

US OTC Switches: FDA Needs Comments To Guide Public Meeting, Congress Wants Progress Report

Agency intends to use information from comments to guide its planning for a public meeting during 2026, according to a Federal Register notice. A GAO report is due in a year to Congress profiling FDA’s progress on making more drugs available nonprescription through OTC switch applications.