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The FDA issued a final guidance on online submissions for certain drug product applications, clarifying that some submission types are exempt or may qualify for a waiver. Read More
The U.S. is bearing the brunt of pharmaceutical research costs because of “free-riding” by foreign countries in the past 15 years, the White House Council of Economic Advisers (CEA) claimed in a new report released yesterday. Read More
The FDA has released a new table listing certain gene-drug interactions backed by scientific evidence that appear on agency-approved drug labeling. Read More
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safety evaluations of new drugs and therapeutic proteins should consider their impact on the immune system, in a draft guidance released yesterday.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