FDA Law Blog
MARCH 15, 2023
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).
FDA Law Blog
DECEMBER 22, 2022
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.
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The Pharma Data
JUNE 2, 2022
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].
FDA Law Blog
AUGUST 21, 2023
The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process. According to FDA, therefore, use in pregnant women is neither condoned nor directed by the labeling—that’s a question for them to discuss with their doctors.
XTalks
MARCH 25, 2024
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.
FDA Law Blog
NOVEMBER 1, 2023
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.
XTalks
FEBRUARY 26, 2021
Hollmann was a doctor at the Kalihi Hospital in Hawaii who wanted to find a way to extract the active ingredients of chaulmoogra oil so that it could be effectively administered to patients. He even became known as the “the plant doctor” among local farmers as he had the ability to improve the health of their fields, orchards and gardens.
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