FDA Law Blog
MARCH 6, 2023
The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda. From a historical perspective, FDA issued a final rule in the Federal Register of July 21, 1978, outlining the current good manufacturing practice (CGMP) requirements for medical devices.
FDA Law Blog
OCTOBER 4, 2022
By Véronique Li, Senior Medical Device Regulation Expert — Allegations of regulatory misconduct are claims that a medical device manufacturer or marketers of medical devices operate in such a way that violates the law. The time in which these requests were completed ranged from months to years.
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FDA Law Blog
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).
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
JANUARY 18, 2022
In October 2014, FDA held a public workshop titled “Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing.” In brief, such devices can be commercially distributed to the general public for non-medical purposes without FDA regulation (e.g., products intended for medical purposes).
FDA Law Blog
AUGUST 4, 2022
Pfizer manufactures tafamidis, a breakthrough treatment for a rare, progressive heart condition known as transthyretin amyloid cardiomyopathy. Most of these cases have settled out of court (see, for example, Actelion Pharmaceuticals , 2018; Astellas Pharma and Amgen , 2019; Gilead Sciences , 2020). Background.
FDA Law Blog
SEPTEMBER 7, 2022
Number of Manufacturing Sites and Registered Products. The report states that for fiscal year 2021, there were 4,451 CDER drug manufacturing sites, which is a 3% increase over fiscal year 2018, the only comparison year provided. For fiscal year 2021, CDER oversaw 12,428 ANDAs, 3,537 NDAs and 315 BLAs. Import Alerts and Recalls.
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