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 …
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Hyman Phelps McNamara
- FDA’s Eighth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers, But the Same PunchlineAugust 23rd, 2016
- FDA Prevails in PRADAXA Patent Term Extension Regulatory Review Period ChallengeAugust 22nd, 2016
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 …
- FDA Issues Calorie Labeling Guidance Documents for Vending Machine OperatorsAugust 21st, 2016
By Riëtte van Laack – On August 15, 2016 FDA simultaneously issued two guidance documents, the Draft Guidance, Calorie Labeling of Articles of Food in Vending Machines and the Final Guidance, Small Entity Compliance Guide (SECG), Calorie Labeling of Articles of Food in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 …
- The UDI Rule: Are Private Label Distributors to be Considered Labelers?August 18th, 2016
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 …
- DEA Policy Expands the Number of Marijuana Cultivators for ResearchAugust 17th, 2016
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 …
- OCP’s Pre-RFD Process: Different Process, Same OutcomeAugust 16th, 2016
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 …
- International Pharmaceutical and Medical Device Supply Chains Imperiled Like Never Before – A Webinar Presented by Dechert LLP and Hyman, Phelps & McNamara PCAugust 16th, 2016
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 …
- A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification May Be More Than a Regulatory ViolationAugust 15th, 2016
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 …
- FDA Issues Long-Awaited Revised Dietary Supplement NDI Draft GuidanceAugust 14th, 2016
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 …
- DEA Issues a Trifecta of Significant Marijuana and Industrial Hemp Decisions, Including Rejecting Rescheduling for Legitimate Medical UseAugust 12th, 2016
By John A. Gilbert, Jr. & Larry K. Houck – In separate notices published today, the Drug Enforcement Administration (“DEA”) issued three major decisions on marijuana and industrial hemp. The most significant, in a move running counter to most state action, includes DEA rejecting a petition …
- DC Circuit Affirms MITIGARE 505(b)(2) NDA Approval, and Sidesteps COLCRYS Patent Certification IssueAugust 11th, 2016
By Kurt R. Karst – In a Per Curiam Judgment handed down last month, the U.S. Court of Appeals for the District of Columbia Circuit affirmed District Court Judge Ketanji Brown Jackson’s January 2015 ruling upholding FDA’s September 26, 2014 approval of a 505(b)(2) application (NDA …
- Assessing the FDA’s Safety DriveAugust 10th, 2016
By Mark I. Schwartz* – On March 2, 2015, investigators from the U.S. Food and Drug Administration walked into a factory at Zhejiang Hisun Pharmaceutical in China to conduct an inspection. According to the investigators, at one point a lab employee pulled a memory stick from …
- While NIH Argues with Congress for Zika Funding, FDA Gives Green-Light to Investigational Release of Genetically Engineered MosquitosAugust 9th, 2016
By Jay W. Cormier – It is no surprise that in a presidential election year that every piece of legislation in Washington gets an extra dose of political theater. Federal funding for Zika virus research is no exception. The President and the NIH have been asking …
- NIH Intends to Open New Manufacturing Facility by End of OctoberAugust 8th, 2016
By Jay W. Cormier – As readers of this blog may recall, FDA observed remarkable conditions at two facilities on the NIH campus in Bethesda, MD (see our post here). Then, earlier this year, NIH stated again that it was closing its drug manufacturing facilities (see …
- Device Developments – The Medical Device Amendments May be Over-the Hill but Device Regulation is Still Very ActiveAugust 8th, 2016
This spring marked the 40th Anniversary of the Medical Device Amendments. Thanks to significant technological advancements there is no sign of slowing down for medical device regulatory developments. Devices were a prominent focus at this year’s Food and Drug Law Institute’s Annual Conference. Sessions included …