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Oncology
Vaccines
Asia
Cell & Gene Therapy
Drug Delivery
Executives
Manufacturing
Facilities
Recalls
Warning Letters
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Special Reports
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Awards Gala
Trending
Supply Chain
AI and Machine Learning
Awards
Outsourcing Awards
Innovation Awards
Pharma Marketing Awards
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Abbreviated New Drug Application
Pharma
Alembic site hit with warning letter on patient consent concerns
After a March inspection yielded a Form 483, Indian generics juggernaut Alembic has received a harsher reprimand from the FDA.
Fraiser Kansteiner
Jul 21, 2026 11:40am
FDA drafts new policies to boost US drug production
Oct 3, 2025 3:52pm
Regulatory tracker: Bayer adds new Kerendia CV outcomes nod
Aug 29, 2022 9:48am
3 months after pulling Pepaxto, Oncopeptides reverses stance
Jan 24, 2022 11:10am
Thermo Fisher helps Civica Rx develop ANDAs to fight shortages
Jan 20, 2020 7:15am
