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

XTalks

FEBRUARY 8, 2021

While the approval pathway for biosimilar products was established 12 years ago, there are still misconceptions about how biosimilars are approved, biosimilarity versus interchangeable status and which patients can be treated with biosimilars. Biosimilars are the “generic” drugs of the biopharma world. What is a Biosimilar?

Production 57

Production Insulin Branding Generic Drugs 57

Camargo

SEPTEMBER 8, 2021

Some Drugs May Require Reclassification to Devices. On August 9, the FDA published a Federal Register notice requesting information and comments regarding products currently classified as drugs which may require reclassification as devices. This is in response to the decision from the U.S.

Development 186

Development Regulation Production Drugs 186

FDA Law Blog

AUGUST 21, 2023

FDA approves (or sometimes dictates depending on the product and regulatory pathway to market) the content of drug product labeling to set forth the conditions of use for which the benefits of the product outweigh the risks.

FDA Approval 40

FDA Approval Production Drugs Generic Drugs 40

Pharmacy Checkers

NOVEMBER 21, 2019

Wikipedia has an extremely long page aptly called Criticism of the Food and Drug Administration , much of it having to do with its role with prescription drugs, and less so other sectors, such as food, tobacco and cosmetics. . It’s primarily the FDA’s role over drug safety and quality that captures my interest and admiration.”.

Generic Drugs 68

Generic Drugs Manufacturing Drugs Regulation 68

XTalks

AUGUST 2, 2023

Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. They are committed to capitalizing on growth opportunities primarily through the advancement of their own product pipeline and constantly improving their existing products, as well as through business development activities.

Sales 91

Sales Manufacturing FDA Approval Life Science 91

Pharmacy Checkers

MARCH 11, 2020

The FDA should be commended for its effort to create rules, pursuant to Section 804 of the Food, Drug and Cosmetic Act, that can lead to a regulated and safe channel of wholesale drug importation from Canada to help reduce cost burdens on states and consumers. counterparts. vs. $30 in the Canada.

Pharmacy 41

Pharmacy Drugs FDA Approval Licensing 41