Regulatory: Page 18

Regulatory

GAO Makes Recommendations to Improve FDA Foreign Inspection Program

Drugs manufactured overseas for the U.S. market must meet the same requirements as those manufactured in the U.S., raising questions about the equivalence of foreign to domestic inspections.

February 9, 2022

Regulatory

FDA Proposes Rule for Wholesale Drug Distributors, Third-party Logistics Providers

If passed, the rule would allow only those licensed according to the proposed national standards to engage in transactions related to the sale and distribution of certain prescription drugs with other members of the supply chain.

February 8, 2022

Regulatory

FDA Publishes Draft Guidance on Reporting Certain Medical Device Shortages

The new guidance helps clarify how the agency interprets 506J notification requirements, including when and who should submit a notification and the information that should be included.

February 1, 2022