Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
Unfortunately, the risk of a cancer diagnosis is a very real concern with many common (and not-so-common) medications. While drug companies have a legal duty to ensure that their medications are safe, these companies don’t...more
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Recently Colleen and Brad had a debate about whether Medical Device Reports (“MDRs”) tend to trail recalls, or whether MDRs tend to lead to recalls. Both Colleen and Brad have decades of experience in FDA regulation, but we...more
On March 22, 2023, at the request of the U.S. Food and Drug Administration (“FDA”), Ascend Laboratories LLC. (“Ascend”) issued a voluntary nationwide recall of certain lots of Dabigatran Etexilate Capsules, a blood thinner...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
In 1969, The Beatles told Jo Jo and Loretta to “get back to where you once belonged.” In 2021, we could view a documentary series by the same name about the recording sessions behind the classic Let It Be album. FDA officials...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more