Industry and patient groups have asked the US Food and Drug Administration (FDA) to make several changes to its revised draft ...

Recon: FDA approves Protagonist and Takeda’s drug for rare blood cancer; Lilly to buy Merida for up to $2.88B Join one of the ...

The Indian government has simplified the regulatory framework for outsourced sterilization of medical devices as part of a ...

The US Food and Drug Administration (FDA) could take additional steps to more successfully implement disclosures of complete ...

Drug manufacturing process models represent a "growing area" of scientific development and are increasingly being utilized in ...

The US Food and Drug Administration (FDA) on Wednesday finalized guidance addressing frequently asked questions related to ...

Office of Prescription Drug Promotion (OPDP) has issued an untitled letter to Alar Pharmaceuticals, accusing the company of ...

Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its pharmacovigilance procedures guidance with new ...

Center for Biologics Evaluation and Research (CBER) has issued a guidance to assist sponsors in assessing potency assays for ...

Pharmaceutical industry groups argue that the US Food and Drug Administration (FDA) should provide clearer guidance on the ...