Won’t Serve in Admin The New York Times has a story about how an FDA regulator’s wife’s tragic fight against cancer opened his eyes to the need to speed up the process for drug approval: In ...

The other day on Fox News’ Jesse Waters Primetime, Calley Means, co-founder of TruMed, a B2B company [1], spoke on how to get the corruption out of scientific guidelines and get at the root ...

has created a trusted drug approval process that could be upended by a case about the medication abortion drug mifepristone that’s being argued Tuesday in front of the US Supreme Court, according to ...

However, there are some situations in which the regulatory process is considered ... potential impact on approvals of the FDA's authority to require REMS (Nature Rev. Drug Discov.

there are 64 oncology drug indications on the US market with accelerated approvals only. The FDA estimates the accelerated ...

The Prescription Drug User Fee Act date refers to the deadline set by the FDA for reviewing a NDA or Biologics License Application.

In a long-sought move, the Food and Drug Administration on Thursday formally began the process of abandoning oral doses of a ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

The committee ruled 12-2 in favor of the drug and its benefit/risk profile, and the drugmaker will now move forward with the process of FDA approval. Although reducing how often patients with MDS need ...

The district court noted that there are no FDA-approved surgical procedures. It also noted that the line between “drug” and “procedure” is ... to remove the fat cells from the fat tissue in a process ...

The FDA has scuttled Merus’ plans to win a speedy approval for i | The FDA has scuttled Merus’ plans to win a speedy approval ...

which is the process of mixing or altering the ingredients of a drug. This precisely occurred with the surge and popularity of Ozempic, a GLP-1 FDA approved drug for diabetes but often prescribed ...