XTalks
DECEMBER 9, 2024
The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions.
Cloudbyz
AUGUST 19, 2024
Answer: Entering the global market requires compliance with various international regulations and standards, including: Regulatory Approval: Devices must meet the regulatory requirements of each country where they will be marketed, such as FDA approval in the U.S., CE marking in the EU, or TGA approval in Australia.
FDA Law Blog
JUNE 9, 2021
Koblitz — While typically, FDA is responsible for setting forth its own agenda and enforcing compliance with its own regulations, the Trump Administration’s HHS, on its way out the door in late 2020 , took the unusual steps of withdrawing an important FDA Compliance Policy Guide, “Marketed Unapproved Drugs – Compliance Policy Guide Sec.
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