2018, Documentation and Medication Dispensing

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2018

Documentation

Medication Dispensing

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. By Philip Won & Lisa M. Wysa, see here ) and addiction (e.g., reSET-O, see here , here ).

Documentation

Documentation FDA Medication Dispensing Hospitals

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

The FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. much like an FDA guidance document. The list of alternative mechanisms for complying with Part 211 in this FR Notice is not different from what was proposed in the 2018 FR Notice. FDA must also review the list periodically. 880.6430 ).

FDA

FDA Medication Dispensing Documentation Packaging

Pharmacy Technician Pulse

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

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

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