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Nearly a year after Sun Pharma began implementing a remediation plan to resolve GMP deficiencies at its Halol, India facility, the FDA continues to fault the company for failing to establish and maintain quality controls in a nine-observation Form 483. Read More
Eli Lilly & Co. had their patent sustained by a federal appeals court, barring generics manufacturer Teva Pharmaceuticals from marketing its own version of the billion-dollar cancer drug Alimta. Read More
Manufacturers seeking approval for generic versions of drug-device combination products, such as prefilled syringes and auto-injectors, should strongly consider minimizing the differences between the generic’s user interface and that of the reference product, FDA advised in new draft guidance. Read More
To help speed the approval of generics, the FDA Friday said it would not wait for the Federal Register to publish determinations that a reference listed drug’s removal from sale had nothing to do with safety and effectiveness. Read More
The Supreme Court has agreed to hear a case centered on whether a 180-day notification is mandatory or optional — when the appropriate disclosures are made — before a biosimilar launch. Read More