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The FDA has issued a final guidance outlining a program that allows stakeholders to propose pharmaceutical quality standards for recognition by CDER, providing industry with additional resources for pharmaceutical development and manufacturing. Read More
Drug-device combination products can pose cumbersome regulatory challenges for companies, say regulatory experts, primarily because the product has to comply with two complicated regulatory systems that are not designed to work together. Read More
Recalls can be messy, complicated matters, especially for manufacturers that don’t have a plan in place for analyzing a problem, determining a course of action and carrying out all recall-related tasks in compliance with FDA requirements. Read More
The FDA has issued final guidance on assessment and control of DNA reactive impurities in harmony with guidance prepared by the International Council for Harmonisation (ICH). Read More
In an open public meeting, the FTC voted 3-0 Thursday to withdraw comments it has issued over the past 13 years in support of pharmacy benefit managers (PBM) – comments the PBM industry has begun using to defend itself in recent public relations campaigns. Read More
Boehringer-Ingelheim, Eli Lilly and Novo Nordisk have added their support to a bipartisan, bicameral bill — the Treat and Reduce Obesity Act (S. 2407 and H.R. 4818) — to expand Medicare coverage of medications and health care specialists to treat obesity. Read More
The letter points out that approximately 32 percent of generic drugs and 45 percent of active pharmaceutical ingredients are from India and China. Read More
Bufferin, a brand synonymous with aspirin for many consumers, features in a head-scratcher FDA action as the agency withdraws the product’s 1948 NDA because the named manufacturer has failed to file required multiple annual reports on the prescription drug, which hasn’t been marketed for years. Read More
This monthly feature consists of excerpts from articles printed in GMP Newsletter LOGFILE, reprinted by permission of the publisher, GMP-Verlag Peither AG. Read More
Republican members of the House Energy and Commerce (E&C) Committee are pressing FDA Commissioner Robert Califf on the effectiveness of the agency’s foreign drug inspection program given that numerous Indian and Chinese firms have repeatedly flouted FDA regulations. Read More