By Jennifer D. Newberger – On September 24, 2014, FDA finalized its guidance document, “Custom Device Exemption,” which explains FDA’s interpretation of the new custom device requirements implemented as part of the Food and Drug Administration Safety and Innovation Act ("FDASIA"). We previously posted on the …
By Jamie K. Wolszon, Allyson B. Mullen & Jeffrey N. Gibbs – Following the July 31, 2014 notification to Congress (see prior post here), FDA wasted no time before formally issuing the draft laboratory-developed test (LDT) Guidance Documents. On October 3, 2014, just four days after …
By Kurt R. Karst – In a September 30, 2014 decision, a unanimous panel of judges from the U.S. Court of Appeals for the Ninth Circuit affirmed an August 2013 decision from the U.S. District Court for the Northern District of California finding that a first-in-the-nation …
By Kurt R. Karst – As most folks know by now, earlier this month the President’s Council of Advisors on Science and Technology (“PCAST”) released a report to the President titled “Combating Antibiotic Resistant Bacteria.” The report is part of a broader initiative announced by The …
By Allyson B. Mullen – As we previously posted, in June 2011, ReGen Biologics, Inc. (“ReGen”), which was subsequently acquired by Ivy Sports Medicine, LLC (“Ivy”), sued FDA based upon the theory that FDA lacked authority under the Federal Food, Drug, and Cosmetic Act (“FDCA”) to …
By Jennifer M. Thomas – For the past few days, industry has reacted with anxiety to the government’s decision to pursue an order to show cause why Bayer, Corp. should not be held in contempt of that company’s 2007 consent decree with FTC due to its …
By Karla L. Palmer – Senators John Cornyn (R-TX) and Sherrod Brown (D-OH) introduced legislation late last week that would allow a pharmacist to dispense a controlled substance prescription for a patient and deliver the drug to a practitioner for administration in the doctor’s office. S. …
By James E. Valentine* – Whether you call it “patient advocacy,” “patient engagement,” or maybe something a little fancier, in recent years incorporating the patient perspective has become a hot topic issue for FDA and drug developers alike. As FDA stated in announcing its Patient Focused …
By Jeffrey K. Shapiro – FDA is authorized by the Federal Food, Drug, and Cosmetic Act of 1938, as amended (FDCA) to regulate the labeling of all medical devices and the advertising only of “restricted devices.” (21 U.S.C. §§ 352(a), 352(q) and (r).) FDA does have …
By Kurt R. Karst – Thanks to everyone who participated in our “30 for 30” Hatch-Waxman Trivia! Based on the corrrespondence we received since posting the trivia questions earlier this week, FDA Law Blog readers enjoyed the trip down memory lane. . . and were entertained along the …
By James C. Shehan – With the posting on Friday of a report, a special advisory bulletin and a podcast, the HHS OIG staked out some new ground in the healthcare fraud and abuse landscape. The report shows that significant numbers of Medicare beneficiaries use copay …
By Ricardo Carvajal & JP Ellison – The U.S. Department of Justice recently announced the convictions of former officials and a broker of the Peanut Corporation of America (“PCA”) – the company at the heart an outbreak of salmonellosis five years ago that was traced to the …
By Kurt R. Karst – It’s difficult to believe that almost 30 years have passed since President Ronald Reagan signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 on September 24, 1984. So much in Hatch-Waxman law (or Waxman-Hatch law if …
By Karla L. Palmer – Late last week, Senators Orrin Hatch (R-UT) and Sheldon Whitehouse (D-RI), both members of the Senate Committee on Health, Education, Labor, & Pensions, announced the introduction of S. 2862, the “Regulatory Transparency, Patient Access, and Effective Drug Enforcement Act.” The legislation …
By Kurt R. Karst – There have been rumors floating around Washington, DC for a few months that efforts were afoot to introduce legislation to amend the FDC Act to address the availability of products subject to a restricted distribution program to generic drug and biosimilar …
