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HPM Calls On FDA to Post on the Internet All Court Filings Regarding Enforcement Actions
…administrative enforcement responsibilities” to, within 120 days, “develop plans to make public information concerning their regulatory compliance and enforcement activities accessible, downloadable, and searchable online.” On March 11, 2011, this…
Frank Sasinowski is a panelist in Wow or Yeow?! FDA Outlook for 2021 and Beyond Webinar
For more information or to register for webinar, click here…
Top Food and Drug Cases 2020 and Cases to Watch 2021
Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in…
Top Food and Drug Cases 2020 and Cases to Watch 2021: GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.
Every year, the Food and Drug Law Institute (FDLI) publishes a compendium of the Top Food and Drug Cases from the previous year, as well as Cases to Watch, in…
FDLI’s Top Food and Drug Cases, 2021 & Cases to Watch , 2022
The U.S. Food and Drug Administration (FDA) had only exercised its authority to ban medical devices twice by the time it finalized its ban on electrical stimulation devices (ESDs) for…
Making Good Decisions When FDA Investigators Come Knocking
…consumer of their products demands the rigor that inspections ensure. John Claud wrote an article about this topic for Med Devices Online. A copy of the full article is attached….
Retailers
…also liable under the Federal Food, Drug, and Cosmetic Act for the violative products they sell in their stores or online. FDA has dramatically shifted its focus to retailers in…
Kurt Karst is speaking at the RAPS RAC (US) Prep Virtual Program
For more information visit conference website…
Should DEA Provide Guidance & Conduct Rulemaking on Suspicious Orders to Ensure Balanced Approach to Reduce Abuse & Ensure Avail. of Needed Medicine?
…most notably the Ryan Haight Online Pharmacy Consumer Protection Act, DEA has failed to provide sufficient guidance in areas, such as suspicious order monitoring and dispensing practices, to be effective….
Ricardo Carvajal is presenting at the Tulane Environmental Law and Policy Summit
…the website for CLE general information or register by clicking the “Online Registration” tab on the upper left corner of this page. General Summit questions? Contact Sam Pfotenhauer, Executive Summit…
D.C. CIRCUIT CORRECTS FDA’S ABUSE OF DISCRETION IN DRUG VS. DEVICE DETERMINATION
Citing agency experience and expertise, courts have long afforded federal agencies discretion in administering their respective statutes. But, in Genus Med. Techs., LLC v. United States FDA, 2021 U.S. App….
Allyson Mullen is speaking at AMDM’s Annual IVD Regulatory Meeting
For more information see meeting website…
Riette van Laack is speaking at FDLI’s Introduction to Food Law and Regulation Conference
For more information see conference website …
Serra Schlanger is speaking at FDLI’s Introduction to Medical Device Law and Regulation Conference
For more information see conference website…
HP&M Takes Home “Law Firm of the Year” Award from U.S. News and Best Lawyers
…with Best Lawyers for the 2021 “Best Law Firms” rankings. We’re truly honored! But the honors don’t stop there. HP&M was also once again ranked as a “Tier 1” law…
Drug industry pushes FDA to solve growing inspection backlog, Politico
Mark is quoted in this article…
HHS Reverses Course on LDTs: COVID-19 LDTs AgainRequire FDA Premarket Review
On November 15, 2021, the U.S. Department of Health and Human Services (“HHS”) and the Food and DrugAdministration (“FDA”) issued several policy changes governing the regulation of Laboratory Developed Tests(“LDTs”)….