By Mark I. Schwartz & Douglas B. Farquhar - After several years of observing an increase in data integrity issues, particularly with overseas drug manufacturers regulated by CDER, on Thursday, April 14th, FDA issued a question-and-answer-based draft guidance entitled “Data Integrity and Compliance with cGMP”. We …
By Riëtte van Laack – As we have reported on several occasions, “natural claims,” particularly when used in the advertising of food and dietary supplements, are frequently challenged by competitors and consumers. Neither the Federal Food, Drug, and Cosmetic Act (FDC Act), nor FDA regulations, nor …
By Jay W. Cormier & Diane B. McColl – This past Tuesday, FDA issued a Notice of Opportunity for Hearing (NOOH) proposing to withdraw approval of all new animal drug applications for carbodox that have an indication for use in medicated swine feed. Specifically, FDA is …
By Riëtte van Laack – Last week, FDA issued the sixth of the seven major rules expected to issue under the authority of the Food Safety Modernization Act (FSMA), namely the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to …
By Allyson B. Mullen – On April 1, FDA issued an updated draft guidance regarding the policies and procedures for Emergency Use Authorizations (EUAs). The EUA procedures cover all types of medical products including drugs and biologics (e.g., vaccines and therapeutics) and devices (e.g., personal protective …
By Allyson B. Mullen – For the past several years, a public-private stakeholder Planning Board has been evaluating the possibility of a new National Medical Device Evaluation System (NMDES). See our earlier posts on this initiative here and here. As discussed in our earlier posts, the NMDES is …
By Jennifer D. Newberger – The Federal Trade Commission (FTC) recently released a guidance titled “Mobile Health App Developers: FTC Best Practices,” intended to provide tips to developers about data security. FTC also released an accompanying on-line tool to assist developers in determining the federal laws …
By Andrew J. Hull – FDA often seeks permanent injunctions against FDA-regulated companies that allegedly run seriously afoul of FDA’s cGMP requirements. FDA usually asks courts, in granting a permanent injunction (the agency’s most powerful civil enforcement tool against U.S. facilities), to order the complete shutdown …
By James C. Shehan – FDA issued it second-ever approval of a biosimilar on Tuesday, April 5, giving the nod to Celltrion’s and Pfizer’s Inflectra, a biosimilar version of J&J’s Remicade (infliximab). The approval follows some of the precedents established in FDA’s approval of the first …
By Riëtte van Laack – As required by the Sunscreen Innovation Act (SIA), FDA published its proposal for the review of Time and Extent Applications (TEAs) for non-sunscreen ingredients (the SIA lays out the framework for sunscreen ingredients). It now is evident that a TEA will …
By Larry K. Houck – The Substance Abuse and Mental Health Services Administration (“SAMHSA”) has published a proposed rule that would increase the number of patients with opioid abuse disorder that a qualified physician can treat with buprenorphine. Medication Assisted Treatment for Opioid Use Disorders, 81 …
For generic drug companies, the biggest and most expensive challenge to a US product launch is the patent that covers the Active Pharmaceutical Ingredient (“API”). Notoriously, only one such patent has ever been invalidated for obviousness. On Thursday, April 14, 2016, from 9:00 AM – 10:00 …
By Jay W. Cormier – Just a little more than four months after FDA approved AquAdvantage Salmon (AAS) – the first genetically engineered (GE) animal intended for food use – several organizations filed suit against FDA and the U.S. Fish and Wildlife Service (FWS) challenging that approval. Plaintiffs …
By Jeffrey N. Gibbs & Allyson B. Mullen – Imagine that you were working at a device company and you received a letter today from FDA saying that FDA was “correcting” the FDA clearance you received nineteen (19 – that is not a typo) years ago. …
By James C. Shehan – On March 31, 2016 FDA released its promised guidance on labeling for biosimilar products. A few parts caught our eye, including another change of mind by FDA on the issue of whether a biosimilar’s labeling should identify itself as a biosimilar, The …
