FDA Law Blog

JULY 25, 2023

Nitrosamines are chemicals that can form during drug manufacturing, known by their scientific names as N-Nitrosodimethylamine (NDMA), N-Nitrosodiethylamine (NDEA), and N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The canary in the coal mine for nitrosamines was their 2018 appearance in blood pressure medications called sartans.

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

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FDA Law Blog

FEBRUARY 28, 2022

The Guidance provides practical advice for device manufacturers to utilize patient engagement in clinical studies. address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”.

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FDA Law Blog

SEPTEMBER 20, 2021

When travel restrictions and public health precautions halt facilities inspections, many sponsors are left wondering how FDA will complete pre-approval inspections and meet their products’ respective PDUFA dates. requesting records in lieu of an inspection, use of information shared by trusted foreign regulatory partners).

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FDA Law Blog

DECEMBER 18, 2022

Generally, FDA’s MDR regulations require device manufacturers to submit Medical Device Reports (MDRs) for individual reportable malfunctions within 30 calendar days of the manufacturer becoming aware of the malfunction. In that letter, FDA stated that it would “permit manufacturers.

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GeriPal

MARCH 2, 2023

JAMA Surgery 2018 Gabapentin and mood stabilizers in the Nursing Home Setting: Antiepileptic prescribing to persons living with dementia residing in nursing homes: A tale of two indications. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. Tasce: I do.

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FDA Law Blog

JUNE 24, 2021

Two years later, in 2018, FDA issued a Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices (see our blog post here ). The 2018 report listed several planned actions by the Agency, one of which was to clarify the difference between servicing and remanufacturing.

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