2018, Documentation, FDA and Medication Dispensing

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2018

Documentation

FDA

Medication Dispensing

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

The FDA Law Blog

SEPTEMBER 26, 2022

Lenz, Principal Medical Device Regulation Expert & Holly N. The 21st Century Cures Act required FDA to publish in the Federal Register a list identifying types of CPs and manufacturing processes that may vary from the requirements of § 4.4, or that FDA proposes can satisfy the requirements in § 4.4 By Adrienne R. 880.6430 ).

FDA

FDA Documentation Medication Dispensing Packaging

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

The FDA Law Blog

OCTOBER 17, 2023

Background The Breakthrough Devices Program, established under section 515B of the Federal Food, Drug, and Cosmetic Act (FD&C Act), is a voluntary program for certain medical devices and device-led combination products. This may be because FDA has already been granting breakthrough designation to devices intended to treat pain (e.g.,

Documentation

Documentation FDA Medication Dispensing Hospitals

Pharmacy Technician Pulse

(Slightly More) Options for cGMP for Combination Products: FDA Describes Alternative or Streamlined Mechanisms for Compliance

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

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