The rollout will allow FDA scientists and subject-matter experts to spend less time on ‘tedious, repetitive tasks,’ the ...

The executive order instructs the FDA to expedite the approval process for domestic pharmaceutical manufacturing facilities.

FDA set to change requirements to get vaccines approved as RFK Jr continues to push skepticism about their use - New FDA ...

This approval marks the 46th successful regulatory inspection for QPS India over the past two decades, including previous audits by the US FDA, EMA, UK MHRA, WHO, ANVISA, NPRA, NABL, GCC ...

Zhong Li’s extensive history with the FDA offers crucial lessons on how companies in the pharmaceutical and biopharmaceutical sectors should approach inspection preparedness.  As an experienced FDA ...

Orchestra BioMed's AVIM earns FDA breakthrough designation, sparking investor optimism. Click here to read why OBIO stock is ...

AI-powered tools are enhancing precision, efficiency, and decision-making in biopharmaceutical development. Recently, Jared ...

Conflicting QSSD definitions from two federal agencies mean that CMS’ administrative authority on drug pricing and payment is ...

A panel at OCT Europe touched upon where the European clinical trial industry is headed and the impact of technology and ...

New research reveals the potential of drugs that have been on the market for decades to treat diseases other than those for ...

President Donald J. Trump issued Executive Order (“EO”) 14293 entitled Regulatory Relief to Promote Domestic Production of ...

The expansion builds upon the agency’s Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program ...