By Riëtte van Laack – On August 17, FDA published in the Federal Register the long awaited final rule, “Substances Generally Recognized as Safe.” The final rule is based on the proposed rule from 1997, and a reopening of the comment period with supplemental questions in …
By Jennifer D. Newberger – Perhaps the most interesting thing about the recently released draft guidance, Deciding When to Submit a 510(k) for a Software Change to an Existing Device, is its mere existence. Historically, all changes to 510(k)-cleared devices were analyzed under the same guidance, …
By Riëtte van Laack – On August 24, 2016, the Food Safety Inspection Service (FSIS) of the U.S. Department of Agriculture announced the availability of its compliance guidance regarding “Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production …
By Jennifer D. Newberger – The long-awaited update to the 1997 guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, was released in draft on August 8. In contrast to its 39-page predecessor, this 73-page document is impressive in the level …
By Kurt R. Karst – Orange Book aficionados may have noticed an interesting entry that recently appeared as an addition to the Orange Book. It came out earlier this month with FDA’s publication of the July 2016 Orange Book Cumulative Supplement (page 1-2C), and also with …
By John A. Gilbert, Jr. & Larry K. Houck – We previously summarized (here and here) the Drug Enforcement Administration’s (“DEA’s”) recent actions related to marijuana and reviewed DEA’s notice that it will expand the number of marijuana cultivators for research. Today we analyze DEA’s denial …
By Kurt R. Karst – Q. Why did the chicken cross the road?A. To get to the other side. Q. Why did the turtle cross the road?A. To get to the shell station. Q. Why did the duck cross the road?A. To prove he wasn’t chicken! Q. Why did …
By Kurt R. Karst – Last month, while this blogger was on vacation enjoying the fine beers of Germany during a tour of that country, the U.S. District Court for the District of Columbia issued a Memorandum Opinion in a rather interesting Hatch-Waxman Patent Term Extension …
By Riëtte van Laack – On August 15, 2016 FDA simultaneously issued two guidance documents, the Draft Guidance, Calorie Labeling of Articles of Food in Vending Machines and the Final Guidance, Small Entity Compliance Guide (SECG), Calorie Labeling of Articles of Food in Vending Machines, to help …
By Jennifer D. Newberger – Though the UDI compliance date for Class II devices is just over one month away, one key question remains unanswered: are private label distributors “labelers” for purposes of the UDI rule? This turns out to be much less clear-cut than it …
By John A. Gilbert, Jr. & Larry K. Houck – Last week we summarized several new Drug Enforcement Administration (“DEA”) actions related to marijuana. We now take a more in depth review of one of those actions related to DEA registration to cultivate marijuana for research. For …
By Jennifer D. Newberger – On August 11, 2016, the Office of Combination Products (OCP) announced a “pre-RFD” process. A Request for Designation (RFD) is the formal process for seeking FDA’s assessment of product classification, for example, determining whether a product should be regulated as a …
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. Furthermore, increased enforcement aimed at the medical …
By Jennifer D. Newberger, Anne K. Walsh & Jeffrey N. Gibbs – The recent issuance of FDA’s draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, which, when finalized, will replace the guidance of the same name issued in January …
By Etan J. Yeshua – Last week, FDA issued for the dietary supplement industry a draft guidance document that largely doubles-down on controversial positions the Agency has previously taken. The draft guidance – “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” – replaces the draft …
