FDA Law Blog

NOVEMBER 6, 2023

is pleased to announce it took top honors in two categories in the 2023 LMG Life Sciences Awards, which recognize the best life science practitioners and firms over the past 12 months from the United States, Canada, and Europe. life sciences industry. WASHINGTON, DC — Hyman, Phelps & McNamara, P.C.

Life Science 40

Life Science Cosmetics Regulation Drugs 40

FDA Law Blog

MARCH 6, 2024

The American Conference Institute (“ACI”) will be hosting a series of go-to forums on critical topics including novel therapeutics, cosmetics/personal care products and Paragraph IV disputes. Claud will be featured at the Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products in New York, NY.

Cosmetics 59

Cosmetics Compliance Generic Drugs Regulation 59

Clinical Trial Podcast

JULY 31, 2022

He is currently the Principal Attorney of Kulkarni Law Firm where he focuses his practice on providing healthcare companies with legal, compliance, and regulatory advice. Last but not the least he is the host of the DarshanTalks livestream interviews where he discusses issues that impact the life science industry.

Clinical Research 80

Clinical Research Clinical Trials Clinical Trials Research 80

pharmaphorum

OCTOBER 27, 2022

To help ensure compliance, it is advisable for companies to establish procedures to assess and verify IT security of social media and digital channels, and to review and monitor company activities, content, and materials. About the authors.

Life Science 86

Life Science Compliance Regulation Cosmetics 86

pharmaphorum

SEPTEMBER 29, 2022

She is the Co-Chair of the firm’s Health Care Practice Group, Co-Chair, Health Care & Life Sciences Sector – Medical Devices, and a core member of the firm’s life sciences and telemedicine industry teams. Kyle Faget is a partner and business lawyer with Foley & Lardner LLP.

Development 87

Development Regulation Production Life Science 87

Pharma in Brief

JANUARY 7, 2024

Section 804 Importation Programs On October 1, 2020, the FDA published a rule entitled Importation of Prescription Drugs (the US Importation Rule ) to implement Section 804 of the Food, Drug, and Cosmetic Act.

Drugs 52

Drugs Regulation FDA Approval Manufacturing 52

XTalks

JUNE 5, 2023

During a drug shortage, compounders might be allowed to prepare a compounded version of the drug provided they meet specific requirements of the Federal Food, Drug, and Cosmetic (FD&C) Act. As of May 2023, both Ozempic and Wegovy were on the FDA’s Drug Shortages list due to a global shortage of semaglutide.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98