Remove Cosmetics Remove Doctor Remove Regulation
article thumbnail

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

FDA Law Blog

FDA , which held that that banning a single intended use of a specific device was inconsistent with the Federal Food, Drug, and Cosmetic Act’s (“FDC Act”) clear pronouncement that FDA cannot regulate the practice of medicine. This provision represents a complete shift in the way FDA is allowed to regulate products.

article thumbnail

FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

FDA Law Blog

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog

Lenz, Principal Medical Device Regulation Expert & Sophia R. 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 ). Gaulkin & Jeffrey N.

article thumbnail

FDA Launches New Dietary Supplement Education Initiative for Consumers, Educators, and Healthcare Professionals

The Pharma Data

As part of the FDA’s ongoing efforts to build awareness around dietary supplements, Supplement Your Knowledge includes the following materials: For consumers: Public education videos and fact sheets with important information about dietary supplements, including how they are regulated and potential benefits and risks. Source link: [link].

article thumbnail

Hitting Pause on Criticism of the FDA, Just for Today

Pharmacy Checkers

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. . billion, about 50% was dedicated to regulating medical products, including prescription drugs.

article thumbnail

Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home

The Pharma Data

doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by a healthcare provider when the test is used at the POC to test individuals younger than 14 years old. It is also authorized for use in point-of-care (POC) settings (e.g., . .

article thumbnail

Oprah Hosts TV Special About GLP-1 Drugs for Weight Loss

XTalks

They work by mimicking the action of the naturally occurring hormone GLP-1, which is involved in regulating blood sugar and appetite. Oprah said she then “released my own shame about it” and consulted her doctor, who prescribed a weight loss medication. “I Obesity is a disease.

Drugs 105