When the FDA finds deep flaws at a manufacturing plant, it questions practices at all other facilities in the network. Hospira found this out in 2010 when a second warning letter in 8 months prompted the FDA to ask it to do a global review, and Wockhardt has now been given a similar regulatory to-do list.
Every time the FDA has discussed compounding pharmacies and the need to keep fake drugs out of the supply chain in recent years, one message has shone through--we need more power. Now, the FDA is being given some, but not all, of the powers it wants, and has begun to discuss how it plans to use its new authority.
When Wockhardt reported financial results in October, regulatory slapdowns in the U.S. and Europe made for a bleak quarter. Now, things are about to get much worse. The FDA has filed an import alert against the plant that generates 25% of Wockhardt's sales.
Now that the FDA has fired off a strongly worded rebuke of its Personal Genome Service, 23andMe is standing by the accuracy of its un-approved test, promising to work with regulators but giving no indication that it'll stop selling its sole product.
Direct-to-consumer DNA testing operation 23andMe has never used the words "diagnostic test" to describe its Personal Genome Service, making pains to note that the test lacks FDA clearance and is "not for diagnostic use." Now, rather strongly, the FDA has stepped in to assert otherwise.
While the recent hack of FDA databases raised plenty of questions about its cybersecurity policies, the agency offered few answers. If a damning new report into government-wide practices is in any way representative of the FDA though, the agency will need to tighten up.
The Drug Quality and Security Act, approved by the Senate Monday and now awaiting the president's signature, lays out limited FDA powers to oversee the compounding pharmacy industry and kicks off the process of establishing a so-called national track-and-trace system
Daniel Galbraith By Daniel Galbraith 2013 was a landmark year for the development of biosimilars. With the global acceptance of biosimilars--also called "follow-on biologics" or...
The reauthorization of PDUFA committed the FDA to giving patients a stronger voice in regulatory decisions, particularly when assessing the benefits and risks of new drugs. The FDA is planning a series of meetings, and Genetic Alliance thinks it's found a way to accelerate the gathering of patient feedback--crowdsourcing.
The automatic budget cuts known as the federal sequester have taken away approximately $85 million in medical device and pharmaceutical FDA user fees away from the agency, the White House's Office of Management & Budget has confirmed.