Someone has got to be on the hook for every prescription drug, be it brand or generic. That’s the policy behind the FDA’s proposed rule that would enable generic drugmakers to change their labels independently of the brand drug.
Whether the needs of the many outweigh the needs of the few is the debate swirling around the FDA’s proposed rule that would allow generic drugmakers to change their labeling independent of the brand drug.
Biosimilar makers have their work cut out for them if they hope to increase the use of their follow-on biologics in Europe. Much of that work is in helping doctors over the learning curve.
Through blogs, Facebook posts, message boards, tweets and other social media avenues, patients share millions of health care-related data each day in the virtual world, creating a real-world goldmine of information for drugmakers willing to listen and engage.
Senators found much to praise at the FDA, but the pace of progress and recent controversial drug approval decisions raised more than a few eyebrows at a Senate Health, Education, Labor and Pensions (HELP) Committee hearing Thursday.
Putting children over politics, senators set aside their differences to unanimously pass a bill that creates a new fund for pediatric research at the National Institutes of Health (NIH). The Gabriella Miller Kids First Research Act now heads to the president for his signature.
Racing ahead of Congress, the Centers for Medicare & Medicaid Services (CMS) withdrew parts of a controversial rule revising the Medicare Part D prescription drug program.
Fearing that India’s lax attitudes toward drug patents might spread to other developing countries, U.S. drugmakers want the U.S. Trade Representative (USTR) to make an example of the country by once again branding it the worst of the worst in not honoring intellectual property (IP) rights.
Whenever the number of drug approvals drops, especially for rare diseases, the FDA points a finger at drugmakers, saying its approvals are limited by the applications it receives.
