Article Topic
What is a 503B outsourcing facility, and why are so many of them uninspected by FDA?
503B outsourcing facilities make our drug supply more resilient, but 81% of 503Bs newly registered since June 2021 have never been inspected by FDA staff. Learn why we recommend changes to this important program.
[...]Prescription Drug Affordability Board Activity, June 2025
Prescription Drug Affordability Board Activity, June 2025 Activities Summary Colorado: Colorado’s next PDAB meeting will be held on August 22, 2025. Maryland: Maryland’s PDAB met on June 23 for updates about federal drug pricing and Maryland’s biotech and life sciences industry. Oregon: At its June 18 meeting, Oregon’s PDAB reviewed survey data and narrowed its…
[...]Government sentencing memo, USA v Avanish Kumar Jha and Rajnish Kumar Jha, July 2024
United States District Court Western District of Washington USA v Avanish Kumar Jha and Rajnish Kumar Jha Indictment Filed July 2025 Read the document.
[...]Defense sentencing memo, USA v Avanish Kumar Jha, Julu 2025
United States District Court Western District of Washington USA v Avanish Kumar Jha Defense sentencing memo Filed July 2025 Read the document.
[...]July 7, 2025: Google to block promotion of pill presses on ads and shopping platforms
The change will affect the Google Ads and Google Shopping platforms starting in September 2025.
[...]FDA announces changes to section 804 importation program proposals
A July 1, 2025 post clarifies that applicants can use “a static baseline approach for the cost-savings analysis” instead of trying to account for changes in unpredictable markets.
[...]June 23, 2025: New botulism outbreaks tied to suspect Botox injections
More than 40 cases of botulism linked to Botox injections have been reported in the U.S. and U.K. over the last two months.
[...]June 16, 2025: Congress passes the HALT Fentanyl Act
The bill permanently schedules fentanyl analogues as Schedule I drugs under the Controlled Substances Act.
[...]June 9, 2025: Two Indian men pleaded guilty to smuggling counterfeit cancer medicine into the U.S.
The Jha brothers admitted selling counterfeit Keytruda and other prescription drugs to undercover agents.
[...]Prescription Drug Affordability Board Activity, May 2025
Prescription Drug Affordability Board Activity, May 2025 Activities Summary Colorado: Colorado’s PDAB met on May 23 to approve the Data Submission Guide and begin rulemaking around an upper payment limit for Enbrel. Oregon: At its May 21 meeting Oregon’s PDAB discussed the timeline and process for affordability reviews and approved the generic drug report. One…
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