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Hyman, Phelps & McNamara (“HPM”) Director Larry Houck will present “Prescribing Red Flags, Corresponding Responsibility and DEA Investigations: What’s a Pharmacist To Do? [read post]

FDA Law Blog - https://www.thefdalawblog.com/

An FDA Inspector’s Knock Will More Likely Be Followed by FDA’s Enforcement Hammer

29 Jan 2023, 6:09 pm by Kurt R. Karst

The analysis was prepared for Pharma Conference’s conference on February 8 and 9 in San Diego (“Current Hot GMP Topics”), linked here, where Hyman, Phelps & McNamara, P.C., Director Doug Farquhar will be presenting on three areas: enforcement areas of primary concern, the conduct of internal investigations, and contacting FDA about inspections. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

FDORA Enacted; HP&M Issues Detailed Summary and Analysis

22 Jan 2023, 9:08 pm by Hyman Phelps McNamara

As we have done in the past for significant laws amending the operative food and drug statutes, Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FDORA. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

ACI’s 40th FDA Boot Camp – March 22-23, 2023 (Virtual)

2 Jan 2023, 7:14 pm by Hyman Phelps McNamara

Karst (Director, Hyman, Phelps & McNamara P.C.). [read post]

FDA Law Blog - https://www.thefdalawblog.com/

Doctoring the Law: Congress May Let FDA Regulate the Practice of Medicine

22 Dec 2022, 12:44 am by Kurt R. Karst

(Hyman, Phelps & McNamara, P.C., was co-counsel for the Judge Rotenberg Center in this litigation.) [read post]

FDA Law Blog - https://www.thefdalawblog.com/

The Relationship Between Outside Counsel Investigations and Quality System Investigations, and What to Do when they Conflict

1 Dec 2022, 7:37 pm by Hyman Phelps McNamara

Anne Walsh of Hyman, Phelps & McNamara PC will be presenting on “The Relationship Between Outside Counsel Investigations and Quality System Investigations, and What to Do when they Conflict” as part of the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference on December 7-8 in Washington, DC. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

HPM Welcomes 15-Year DOJ Veteran, John W.M. Claud, to the Firm

15 Nov 2022, 2:16 pm by Hyman Phelps McNamara

Hyman, Phelps & McNamara, P.C. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

FUFRA Enacted; HP&M Issues Detailed Summary and Analysis

9 Nov 2022, 3:39 pm by Hyman Phelps McNamara

As we have done in the past for the initial and each quinquennial reauthorization of the drug and medical device user fee laws—in 1992, 1997, 2002, 2007, 2012, and 2017—Hyman, Phelps & McNamara, P.C. has prepared a detailed Summary and Analysis of FUFRA. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

Farming for Food Law: Locating Food Law Resources in Honor of World Food Day

18 Oct 2022, 12:00 am by Kerri-Ann Yanique Rowe

Here are a few blogs to help stay connected with the latest happenings in food law: The National Agricultural Law Center: The Ag & Food Law Update Hyman, Phelps & McNamara, P.C. - FDA Law Blog UCLA School of Law Resnick Center for Food Law & Policy - On Food Law Hogan Lovells - Food Law [read post]

Carolina Blawg - https://library.law.unc.edu/blog/

HP&M Promotes James Valentine to Director

16 Oct 2022, 7:12 pm by Kurt R. Karst

Karst —Hyman, Phelps & McNamara, P.C. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

A Historic Day in Drug Development: FDA Approves Amylyx’s Drug to Treat ALS, Demonstrating FDA’s Application of Appropriate Flexibility in Rare Diseases

29 Sep 2022, 5:56 pm by Kurt R. Karst

Hyman, Phelps & McNamara, P.C. [read post]

FDA Law Blog - https://www.thefdalawblog.com/

FDAnews Webinar: Califf’s Post-PDUFA, Post-COVID FDA Agenda: Key Developments, Insights and Analysis

12 Sep 2022, 6:30 pm by Hyman Phelps McNamara

Hyman, Phelps & McNamara, P.C. [read post]