Ready, Set, START – 7 Programs Selected for FDA’s START Rare Disease Pilot...
By Sarah Wicks & Charles D. Snow & James E. Valentine & Frank J. Sasinowski —Hyman, Phelps & McNamara (HPM) would like to congratulate the 7 rare disease programs selected for the...
View ArticleScrub-a-Dub-Dub: FTC is Cleansing the Orange Book of Device Patents
By Sara W. Koblitz —As we have noted for the last year or so, the FTC has been on a mission to clean up the Orange Book by removing what it deems to be “improper” patents. The FTC has put out policy...
View ArticleClik here to view.
OPQ’s State of Pharmaceutical Quality Report Is a Data Bonanza (with Cameos...
By Kalie E. Richardson & John W.M. Claud —FDA’s Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) is charged with assuring that drugs marketed in the U.S....
View ArticleDEA’s Expected Guidance: It Should Reduce Current “Pain” at the (Intrathecal...
By John A. Gilbert & Karla L. Palmer —For more than 50 years, the Drug Enforcement Administration (DEA) has enforced the central mandate of the Controlled Substances Act (CSA) to maintain a closed...
View ArticleHPM Director Dara Katcher Levy to Present Webinar on AMCP Format for...
This afternoon Hyman, Phelps & McNamara, P.C. (HPM) Director Dara Katcher Levy will present an informative webinar on the newly released AMCP Format for Formulary Submissions version 5.0. The...
View ArticleThe Interchangeables Are A-Changin’: New FDA Guidance Proposes Eliminating...
By Sara W. Koblitz —In a short but sweet Guidance issued last week, FDA proposed a dramatic change to the way it evaluates interchangeable biosimilars. For the last 14 years, an applicant could get...
View ArticlePreSTAR: a New Template for Pre Submissions and 513(g) Requests for Information
By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert —FDA recently released a new eSTAR template for device pre-submissions...
View ArticlePharmacists in Florida (and Elsewhere): Waive Prescribing Red Flags at Your...
By Larry K. Houck —We blogged in February 2022 about the Drug Enforcement Administration’s (“DEA’s”) revocation of Gulf Med Pharmacy’s registration after finding that it failed to exercise its...
View ArticleRAPS Convergence 2024 to Feature Session on Accelerating Breakthrough Device...
RAPS Convergence 2024 is set to host a must-attend session on CDRH’s Total Product Life Cycle Advisory Program (TAP), promising attendees an exclusive insight into a pioneering initiative aimed at...
View ArticleFormer DEA Administrators Weigh in on Marijuana Rescheduling
By Larry K. Houck —The Drug Enforcement Administration (“DEA”) has received more than 27,000 public comments in response to its May 21, 2024, Notice of Proposed Rulemaking (“NPRM”) to reschedule...
View ArticleWinter is Coming: How a Labor Case in SCOTUS Impacts FDA Injunction Powers
By JP Ellison & John W.M. Claud —Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § 332. That statute provides that courts...
View ArticleLess than Meets the Eye: LDT Small Entity Compliance Guide Adds Little Insight
By Gail H. Javitt & Lisa M. Baumhardt, Senior Medical Device Regulation Expert —In its final rule on laboratory developed tests (LDTs) (see our prior blog here), FDA acknowledged that “some...
View ArticleSupreme Court Rules that SEC and Potentially Other Agencies Cannot Impose...
By Riëtte van Laack & JP Ellison —On Thursday, the 27th of June, the Supreme Court issued its decision in Securities and Exchange Commission v. Jarkesy. The court ruled that the Securities and...
View ArticleBetter Late Than Never – Unpacking FDA’s Highly Anticipated (and Long...
By Mark A. Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & Sarah Wicks & Deborah L. Livornese —The Food and Drug Omnibus Reform Act (“FDORA”), enacted in December 2022,...
View ArticlePower to the Patient with Patient Generated Health Data
By Adrienne R. Lenz, Principal Medical Device Regulation Expert —FDA’s Center for Devices and Radiological Health (CDRH) recently partnered with the Digital Medicine Society (DiMe) to host a two-day...
View ArticleThrough the Looking Glass? Loper Bright Will Force FDA to Change Its Approach...
By John W.M. Claud & JP Ellison —The Supreme Court’s recent decision in Loper Bright v. Raimondo has done away with Chevron deference to federal agencies’ interpretation of ambiguous statutes,...
View ArticleAt Long Last, FDA Unveils Plan for Rare Disease Innovation Hub
By Sarah Wicks & James E. Valentine & Frank J. Sasinowski —On July 17, 2024, FDA announced the establishment of a Rare Disease Innovation Hub (the “Hub”) to enhance and improve outcomes for...
View ArticleStand by Your Case? Without Standing, Supreme Court Precedent Means You’ll...
By John W.M. Claud —Sometimes it’s difficult to be a plaintiff, putting all your work into just one case. That’s especially true if recent Supreme Court rulings have rendered your matter a quixotic...
View ArticleACI’s Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care...
The American Conference Institute (“ACI”) is holding its 2nd West Coast Editionof its Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products from September 25-26 at the Le...
View ArticleFDA Releases Draft Guidance on Essential Drug Delivery Outputs
By Adrienne R. Lenz, Principal Medical Device Regulation Expert —For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance...
View Article
