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The sharp increase in FDA warning letters to Indian facilities last year will lead to a significant delay in U.S. generic launches by Indian drugmakers, according to CRISIL, an Indian research firm. Read More
The FDA issued a final rule amending the definition of “biological product” to include chemically synthesized polypeptides, a category of products that includes all insulins currently on the market. Read More
The FDA slapped a German contract manufacturer with a Form 483 for serious data integrity violations found in an inspection of its facility in Bavaria. Read More
The FDA details how sponsors of nonclinical safety evaluations of new drugs and therapeutic proteins should consider their impact on the immune system, in a draft guidance released yesterday. Read More
A coalition of unions and patient advocacy groups has urged the Federal Trade Commission to strengthen its requirements for AbbVie and Allergan’s planned $63 billion merger. Read More
The Attorneys General of a dozen states and the U.S. Chamber of Commerce have urged a federal appeals court to dissolve the novel “negotiating class” in the multidistrict opioid litigation, arguing that Judge Dan Polster of the U.S. District Court for the Northern District of Ohio lacked the legal authority to create it. Read More