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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
The FDA will revise its recommendations for the submission of quality metrics and provide advice on comparative analyses for drug-device generics before the year ends. Read More
The U.S. Department of Justice issued grand jury subpoenas to Taro Pharmaceuticals and two of the company’s senior officials over the pricing of its generics, the drugmaker revealed in an SEC filing. Read More
The FDA expects to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More