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Revised Final Guidance on Nitrosamines Offers New Recommendations for Assessment and Control

FDA Law Blog

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. By John W.M.

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The Future Of Vision And Eye Care

The Medical Futurist

How far can you see and hear? When it comes to vision, it’s around 50 miles, talking about hearing, it’s only 1-2 miles at best! What about the smell of the flowers? Without the wind blowing, only 10-20 metres. How about touching or tasting? Well, it depends on your arm’s length, but obviously not further than that. Globally 1.1

Diabetes 105
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Patients Preferences and Difficulties with 5 Different Fecal Immunochemical Tests (FITs) [Screening, prevention, and health promotion]

Annals of Family Medicine

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.

Screening 130
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The Most Engaging Decision You’ll Read All Year – Five Stars

FDA Law Blog

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.

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FDA Inspections Back Up To Speed (Except Those Now Deemed Unnecessary)

FDA Law Blog

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.

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Here It Goes, Here It Goes, Here It Goes Again: The Build Back Better Act (Redux)

FDA Law Blog

With 190 pages dedicated to prescription drug pricing reform, the program is ambitious…and complicated. As a threshold matter, the 2-year delay provision does not solve the core problem for biosimilars manufacturers: the lack of predictability that Build Back Better injects into biosimilar development.

IT 52
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A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities. and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers

FDA Law Blog

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)