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The Office of Generic Drugs topped last year’s approval and rejection rates, issuing 835 tentative or full approvals and 1,725 complete response letters in fiscal 2016. Read More
The EMA Management Board has advanced the development of a web portal that will provide free information on European medicines across the products’ lifecycle. Read More
The pharmaceutical industry is generally satisfied with the EMA’s redesigned post-approval procedures, but would like some clarity on how to tackle more complex filings, according to an EMA survey. Read More
A federal judge ruled that Apotex’s biosimilars of Amgen’s Neulasta and Neupogen do not infringe on a patent that covers a protein refolding process. Read More
Alcon Pharmaceuticals is asking the FDA to apply stricter requirements on bioequivalence studies intended to supplement applications for Durezol and Ciprodex generics. Read More
The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency. Read More