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. Furthermore, patients should only purchase Ozempic, Wegovy or other medications from licensed healthcare providers or pharmacies.

FDA Approval 98

FDA Approval Containment Drugs Pharmacy 98

pharmaphorum

SEPTEMBER 29, 2022

Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.

Development 100

Development Regulation Production Life Science 100

FDA Law Blog

FEBRUARY 29, 2024

156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. Moreover, Lilly should explain how a PTE application for a withdrawn “revoked” biologics license application is in compliance with requirements of 37 C.F.R.

Production 59

Production Drugs FDA Approval Compliance 59

FDA Law Blog

AUGUST 17, 2022

Further, FDA explained that state consumer protection laws can continue to be imposed through any licensing requirements that remain for hearing care professionals, meaning that some consumer protection laws may apply to some OTC hearing aids but not others depending on the seller. In other words, it’s a get-what-you-pay-for type situation.

Licensing 40

Licensing Licensing Regulation Marketing 40

Pharma in Brief

JANUARY 10, 2024

Case law updates In 2023, the Patented Medicines (Notice of Compliance) Regulations ( Regulations ) turned 30 years old, inspiring our litigators to consider how the Regulations have evolved since 1993 (see here ). billion over three years to help increase drug access and affordability (see here ).The

Regulation 52

Regulation Drugs Production Medicine 52

pharmaphorum

OCTOBER 4, 2022

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Criteria for regulation. Prior to joining the firm, Kyle held in-house positions at pre-commercial and commercial stage companies.

Development 103

Development Regulation Cosmetics Life Science 103

FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.

Regulation 81

Regulation In-Vitro Manufacturing Licensing 81