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Podcast: Talking the cure
11 April 2024
Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...
Publications
News
Florida still has a long way to go before it can begin importing certain Canadian drugs
09 January 2024
On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next...
News
FDA warns animal drug companies over unapproved antimicrobials, identifying “public health concerns”
29 December 2023
In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal...
News
Inside the FDA Advanced Manufacturing Technologies Designation Program
15 December 2023
On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development...
News
U.S.: FDA enforcement of certain DSCSA requirements delayed until November 2024
06 September 2023
The U.S. Food and Drug Administration (FDA) recently published a guidance for immediate implementation, Enhanced Drug Distribution Security Requirements Under Section 582(g)(1), that...
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Can sterile drug manufacturers implement EU GMP Annex 1 requirements before August?
17 January 2023
In August 2022, the European Commission published a revision to Annex 1 “Manufacture of Sterile Medicinal Products” in EudraLex - Volume 4 - Good Manufacturing Practice (GMP)...
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FDA expands inspection obstruction guidance to apply to device facilities
10 January 2023
The U.S. Food and Drug Administration (FDA) has published the revised draft guidance “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device...
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Modernization of U.S. cosmetics regulation will be phased in over time
05 January 2023
On December 29, 2022, U.S. President Biden signed into law the "Consolidated Appropriations Act, 2023," which includes the Modernization of Cosmetics Regulation Act of 2022...
News
New FDA pilot offers expedited drug program sponsors expanded FDA meeting opportunities on manufacturing issues
23 November 2022
Starting April 1, 2023, the U.S. Food and Drug Administration (FDA) will begin accepting requests to participate in a new Chemistry, Manufacturing, and Controls (CMC) Development and...
