FDA Law Blog
SEPTEMBER 11, 2024
Nitrosamines are impurities that can form during drug manufacturing and are considered potentially potent carcinogens. For example, depending on the manufacturing process for a specific human drug, the use of some specific solvents, reagents, and catalysts may trigger the formation of these possible carcinogens.
Annals of Family Medicine
NOVEMBER 20, 2024
FITs would save nearly as many lives as colonoscopy with far fewer complications. FIT manufacturers should develop very clear directions for patients. Context: FITs are an accepted method of colorectal cancer (CRC) screening and patients’ preferences and difficulties are unknown. Multiple FITs are available in the U.S.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
FDA Law Blog
AUGUST 16, 2022
Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. By Douglas B. Mr. Cruse pledged that the frequency of these inspections would increase.
FDA Law Blog
JANUARY 15, 2024
FDA , Petitioners, a liquid nicotine manufacturer, sued FDA arguing that the Agency was arbitrary and capricious in rejecting the Petitioner’s Premarket Tobacco Application (“PMTA”) in violation of the Administrative Procedure Act (“APA”). FDA also directed manufacturers to produce detailed marketing plans.
FDA Law Blog
NOVEMBER 16, 2021
1) publish a list of selected drugs in accordance with section 1192; (2) enter into agreements with manufacturers of selected drugs with respect to such period, in accordance with section 1193; (3) negotiate and, if applicable, renegotiate maximum fair prices for such selected drugs, in accordance with section 1194; and. (4)
FDA Law Blog
JULY 29, 2024
Last week, FDA issued draft guidance to address the potential complications that arise when sponsors seek to modify products, production processes, or quality controls for approved biologics license application (BLA) biosimilar and interchangeable products. Part 601 delineates those changes as being either major, moderate, or minor.
The Medical Futurist
JUNE 21, 2025
While it is really difficult to manufacture a contact lens, which is one-third of a millimetre in diameter, a 3D printer sandwiches together different layers of interacting material, which makes it easier to match tiny pieces.
Expert insights. Personalized for you.
105 
Let's personalize your content