On February 19, 2015, FDA granted de novo authorization to 23andMe for genetic tests for autosomal recessive traits that are offered directly to consumers (DEN140044). Nearly three years later, FDA has proposed a pathway that opens this avenue further. In a statement on November 6 …
On October 30, CDRH issued the Final Guidance “De Novo Classification Process (Evaluation of Automatic Class III Designation)” (the “De Novo Guidance”). This is a final version of the 2014 draft by the same name (see our earlier blog post here). On the same day, …
Sherman, set the Way-Back Machine. A press release from the U.S. Department of Justice announced that the former Compliance Director of Pharmakon Pharmaceuticals, Inc. has pleaded guilty in Indiana to conspiring to defraud the United States government by lying about failed potency tests of drugs that …
Although the Drug Supply Chain Security Act of 2013 (DSCSA) required publication by 2015 of guidance addressing grandfathering of certain product identifier requirements for packages or homogeneous cases of finished dosage form prescription drugs, “its better late than never,” as the saying goes. On Monday …
The recently-enacted Food and Drug Administration Reauthorization Act (“FDARA”) includes the Medical Device User Fee Amendments of 2017 (“MDUFA IV”) (see our summary here). This new law affects multiple aspects of the device review process. MDUFA IV supplements FDA’s funding of device regulation, with the goal …
Last week FDA formally announced yet another transparency initiative – this time, it’s the inclusion of patent submission dates in the Orange Book! (FDA informally announced the change a couple of weeks ago with a note in the Orange Book stating: “Effective November 21, 2017, …
On October 30, CDRH finalized the guidance entitled, “Manufacturers Sharing Patient-Specific Information From Medical Devices With Patients Upon Request”. This is the final version of the guidance, “Dissemination of Patient-Specific Information from Devices by Device Manufacturers” issued in June 2016 (see our blog post on …
The Food and Drug Law Institute’s (“FDLI”) Enforcement, Litigation, and Compliance Conference is just a few weeks away, and spaces are going fast! The two-day conference will be held on December 6-7, 2017, in Washington, D.C. Hear from new government officials, including Rebecca Wood, the …
The American Conference Institute’s Legal, Regulatory, & Compliance Forum on Controlled Substances is scheduled to take place in Washington, D.C. from January 29-31, 2018. Esteemed, top-notch faculty speaking at the conference include current and former officials from the DEA and FDA, representatives from State Attorney General …
On November 14, 2017, the USDA Agricultural Marketing Service (AMS) announced that it will further delay and reconsider the Organic Livestock and Poultry Practices (OLPP) regulations. This is not the first delay of the effective date for the OLPP regulations. The OLPP final rule amends the …
If you happened to log on to the FDA Law Blog or the Hyman, Phelps & McNamara, P.C. (“HPM”) websites over this past weekend, then you probably noticed some big changes. We’ve totally overhauled and upgraded the blog and the HPM websites to bring them …
Small business owners and managers of chain restaurants subject to FDA’s menu labeling rule remain confused as to the criminality of adding an extra dollop of ketchup to a hamburger. One thing is now clear — the only way to stop FDA’s years of wasteful …
You may be a doctor, dentist, veterinarian, pharmacy, wholesale distributor, or manufacturer, and you just received an Order to Show Cause from the Drug Enforcement Administration (DEA). An Order to Show Cause can have a significant impact on your ability to handle controlled substances and, …
On October 25, 2017, FDA issued a final guidance: Deciding When to Submit a 510(k) for a Change to an Existing Device. This guidance is a final version of the draft issued in 2016 (see our post on the 2016 draft here). Despite receiving a …
Last week, FDA did something unprecedented (although not unexpected, at least by this blogger)! And based on the absence of any reporting in the trade press or online chatter, nobody seems to have taken note of FDA’s decision. In a November 6, 2017 response to …
