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4 Mar 2021, 1:17 am by Kurt R. Karst
Moore & Ricardo Carvajal & Riëtte van Laack — Welcome to the latest edition of Hyman, Phelps & McNamara, P.C. [read post]
9 Feb 2021, 2:26 am by Hyman Phelps McNamara
A distinguished cast of presenters will share their knowledge and provide critical insights on a host of topics, including: The organization, jurisdiction, functions, and operations of FDA The essentials of the approval process for drugs and biologics Clinical trials for drugs and biologics The role of the Hatch-Waxman Act in the patenting of drugs and biologics Labeling in the drug and biologics approval process cGMPs and other manufacturing concerns relative to products liability Proactive adverse… [read post]
4 Feb 2021, 1:52 am by Hyman Phelps McNamara
Hear from leading OTC industry counsel and regulatory executives who will provide timely analysis and best practices for: Preparing for monograph reform under the CARES Act Substantiating COVID-related claims Identifying labeling and manufacturing missteps for imports, to avoid costly hold ups at the border Leveraging lessons from recent Rx-to-OTC switch success stories to overcome complex legal and regulatory hurdles Navigating recalls and adverse events protocols Hyman, Phelps… [read post]
28 Jan 2021, 2:29 am by Hyman Phelps McNamara
  To name just a few, they include Dan Schultz, former director of CRRH; Nina El-Badry of BARDA; and Sally Hojvat, who was Director of one of the IVD Divisions at CDRH and now consults with WHO; and several colleagues at Hyman, Phelps & McNamara, P.C., and other law firms. [read post]
5 Jan 2021, 9:36 pm by Kurt R. Karst
Moore & Ricardo Carvajal & Riëtte van Laack — Welcome to the final 2020 edition of Hyman, Phelps & McNamara, P.C. [read post]
4 Jan 2021, 9:06 pm by Kurt R. Karst
Hyman, Phelps & McNamara, P.C. has prepared a memo summarizing this wide-ranging final rule (available here). [read post]
7 Dec 2020, 3:27 am by Kurt R. Karst
Moore & Ricardo Carvajal & Riëtte van Laack — Welcome to the latest edition of Hyman, Phelps & McNamara, P.C. [read post]
4 Dec 2020, 1:50 am by Hyman Phelps McNamara
To close out 2020, Hyman, Phelps & McNamara, P.C. is pleased to present the latest issue of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. [read post]
17 Nov 2020, 8:42 pm by Hyman Phelps McNamara
Hyman Phelps & McNamara, P.C. is pleased to announce that Sara Koblitz has been promoted to Counsel at the firm. [read post]
22 Oct 2020, 2:18 am by Hyman Phelps McNamara
Hyman, Phelps & McNamara PC is co-hosting this conference on “LawSeqSM: Facing the Legal Barriers to Genomic Research & Precision Medicine. [read post]
16 Oct 2020, 1:55 am by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. is pleased to announce that Dara Katcher Levy and Serra Schlanger will present at the Food and Drug Law Institute’s virtual Advertising and Promotion for Medical Products Conference on October 28–30, 2020. [read post]
8 Oct 2020, 3:51 am by Kurt R. Karst
Moore & Ricardo Carvajal & Riëtte van Laack — Welcome to the inaugural edition of Hyman, Phelps & McNamara, P.C. [read post]
29 Sep 2020, 1:22 pm by Hyman Phelps McNamara
Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, a virtual conference, on November 16–17, 2020. [read post]