By Allyson B. Mullen – On January 4, CDRH issued its first draft device guidance of the year. The Draft Guidance “Unique Device Identification: Convenience Kits” explains FDA’s position as to what constitutes a convenience kit for purposes of the UDI Rule. The guidance is quick to …
By Melisa M. Moonan – It has come to our attention that FDA has initiated inspections at several hospitals in various parts of the country to assess compliance with User Facility Medical Device Reporting (MDR) obligations under section 519 of the Federal Food, Drug, and Cosmetic …
By James E. Valentine – On January 13, 2015, CDER’s Clinical Outcome Assessments Staff (formerly Study Endpoints and Labeling Development (SEALD)) announced the launch of Stage 1, or the pilot stage, of its Clinical Outcomes Assessment (COA) Compendium. A COA measures patients’ symptoms, overall mental state, or …
By Kurt R. Karst – A few months have passed since the appeals Takeda Pharmaceuticals U.S.A., Inc. (“Takeda”) and Elliott Associates, L.P., Elliott International, L.P. and Knollwood Investments, L.P. (collectively “Elliott”) filed with the U.S. Court of Appeals for the District of Columbia Circuit after …
Hyman Phelps & McNamara P.C. (“HP&M”) is pleased to announce that Mark I. Schwartz has joined the firm as Of Counsel. Mr. Schwartz advises clients on biologic, drug, and device compliance, as well as on regulatory issues. He joined the firm after spending close to …
By Allyson B. Mullen – On New Year’s Eve, FDA gave an end of the year surprise to the device industry: the draft guidance “Public Notification of Emerging Postmarket Medical Device Signals ('Emerging Signals').” FDA indicates that the purpose of the guidance is to provide information …
By Ricardo Carvajal – FDA announced the seizure of dietary supplements purportedly containing kratom, which the agency describes as “a botanical substance that could pose a risk to public health and have the potential for abuse.” The seizure followed on the heels of an administrative detention – a …
By Larry K. Houck – Several recent developments relating to cannabidiol and marijuana occurred over the past several weeks. We summarize them below: One Step Forward for Cannabidiol Research The Drug Enforcement Administration (“DEA”) announced that it has eased some of the regulatory requirements for FDA-approved clinical trials …
By James C. Shehan – The worlds of FDA regulatory law and employment law rarely intersect, so when we came across a recent case in which they did, we thought it worthy of commentary. In that case, a federal appeals court held that GMP troubles leading …
By Allyson B. Mullen – In August, CDRH quietly implemented a new version of the 510(k) Refuse to Accept (RTA) Policy in a draft guidance, titled "Refuse to Accept Policy for 510(k)s" (New RTA Guidance). This change was done with so little fanfare that many did not …
By Riëtte van Laack – On December 23, 2015, FDA issued a proposed rule amending the regulations for prescription and over-the-counter (OTC) fixed-combination products, co-packaged drugs, and combinations of active ingredients under consideration for inclusion in an OTC monograph. The 20-page proposal is intended to harmonize …
By Riëtte van Laack – “Native advertising” is advertising that looks like “news, feature articles, product reviews, entertainment, and other material surrounding it.” In the digital context, native advertising constitutes marketing material that is designed to mimic the look and feel of the host website. It …
By Alexander J. Varond – On December 18, Congress extended the rare pediatric disease priority review voucher (pediatric PRV) program out to September 30, 2016. The extension was granted as part of Congress’s budget deal. Although modest, it has been welcomed by industry. Many hope, however, …
By Kurt R. Karst – The once nascent biosimilars industry took off in 2015 with the first biosimilar approval (ZARXIO [filgrastim-sndz], which FDA licensed on March 6, 2015 under BLA 125553), myriad court decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) (see …
By James E. Valentine & David B. Clissold – In an annual update presented at the FDA/CMS Summit on December 14, 2015, Dr. John Jenkins, Director, Office of New Drugs, the Center for Drug Evaluation and Research (CDER or the Center), provided metrics and insights into …
