InvaGen Pharmaceuticals Inc.
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Latest From InvaGen Pharmaceuticals Inc.
Will US FDA Offer Regulatory Flexibility For ANDAs Downgraded Because Of CRO Investigation?
Complex generic may have some wiggle room, but the only choice for many sponsors may be to redo the affected studies or withdraw the products that have lost bioequivalence status after FDA questioned the integrity of the data from two contract researchers.
More Than 100 Applications Lost Equivalence Rating Thanks To Allegedly Falsified Data At Two CROs
Sponsors must decide whether to repeat bioequivalence and other studies after two CROs were found to have potentially falsified data, causing the US FDA to reject all data produced by the firms.
Cipla-SIGA Antibacterial Alliance To Tackle Resistance, Biothreats
Cipla, which has long-standing experience in antibiotic development in India, strikes alliance with US firm SIGA Technologies. The partners are targeting novel antibacterials, especially against biothreats, and expect to cater to US agency BARDA, among others.
Keeping Track: Recent NDA Submissions Range From Acute Agitation To Von Hippel-Lindau Disease
News and highlights of applications submitted for US FDA approval, from the Pink Sheet’s FDA Performance Tracker
- Generic Drugs
- Controlled Release
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