The years-long battle over 5-year New Chemical Entity (“NCE”) exclusivity for Ferring Pharmaceuticals Inc.’s (“Ferring’s”) colonoscopy preparation, PREPOPIK (sodium picosulfate, magnesium oxide, and citric acid) for Oral Solution (NDA 202535; approved on July 16, 2012), may finally be at an end (pardon the pun). Last …
On February 13, 2018, the USDA Food Safety and Inspection Service (FSIS) published a proposed rule that would amend the egg products inspection regulations. The proposal had been announced on January 9, 2018. The 48-page proposal (including the preamble) covers more than a change in …
On Monday, the Trump Administration released a proposed Fiscal Year 2019 Budget. Tucked into the Proposed Budget are provisions concerning 180-day generic drug exclusivity that garnered quite a bit of discussion earlier this week at the Annual Meeting of the Association for Accessible Medicines in …
Clean or cultured meat are terms used for animal muscle produced by growing cells directly rather than via the rearing and slaughtering of an animal. The idea of growing meat (or muscle) from cells outside the body (in vitro) to produce a product that replicates …
Barely a week apart, FDA announced the publication of a slew of guidance documents intended to further implement the food supply chain-related provisions of the Food Safety Modernization Act (FSMA). In this posting, we look at the first set of documents, published on January 24. …
Buried in the 250 pages of the Bipartisan Budget Act of 2018 (BBA 2018), which was signed by President Trump on Friday, February 9, are several provisions directly affecting the discounts brand drug manufacturers must pay under federal drug benefit programs: Increase in Part D Coverage …
The Center for Devices and Radiological Health (CDRH) says it has a plan for fostering digital health innovation while reimagining the regulatory oversight to provide patients with access to safe and effective digital health products. One step in the plan is developing a Digital Health …
On Friday, February 9, 2018, from 2:00-3:30 PM ET, the Food and Drug Law Institute (“FDLI”) will be hosting a webinar, titled “New Medical Device Requirements and Where Manufacturers Should Focus: MDUFA, FDARA, and 21st Century Cures.” Hyman, Phelps & McNamara, P.C.’s Jeffrey N. Gibbs …
The third-party 510(k) review process was an emphasis in the most recent user fee negotiations and statutory changes under the FDA Reauthorization Act of 2017 (FDARA). This process has been criticized in the past for being restrictive, ineffective, and not beneficial for applicants. On January …
On Monday, January 21 (amid the government shutdown) the Center for Veterinary Medicine of the Food and Drug Administration (CVM) released a draft guidance document addressing Subpart C of the Agency’s regulation titled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food …
On January 30, 2018, Dr. Gottlieb of FDA and Secretary Perdue of the USDA announced that they had signed a formal agreement to make the coordination and collaboration between the two agencies more efficient and effective. The USDA has jurisdiction over most meat, poultry, catfish, and …
The fact is, regulatory compliance has an impact on products liability. Yet, the two are seldom considered together. We aim to change that with a special day and a half program (April 12th and 13th). Our FDA regulatory firm has teamed up with a renowned medical …
Vape shops in several states have banded together in litigation challenging the constitutionality of FDA’s Deeming Rule (for background information on that regulation, see our prior posting here). Plaintiffs are pursuing the litigation simultaneously in several federal district courts – perhaps with the objective of …
Last month, the U.S. Court of Appeals for the Eleventh Circuit affirmed prison sentences for Stewart and Michael Parnell, and Mary Wilkerson, formerly of the Peanut Corporation of America (PCA). If you missed our earlier coverage of this historic case (here and here), PCA was …
On January 17, 2018, in an effort to overhaul the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey introduced bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and Reform Act, S.2315. As readers of this blog know, the current monograph system, which …
