2 Day FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: Sept 24th - Sept ...

Market opportunities include gaining a comprehensive understanding of FDA procedures for US pharmaceutical submissions, critical for navigating the largest global market. This course provides deep ...
RAPS

New FDA Document Clarifies IND Process for Drugs, Biologics and Biosimilars

A new procedural document issued by the US Food and Drug Administration (FDA) instructs its staff on the best practices-known as Good Review Practices (GVPs)-used in the review of investigational new ...
RAPS

FDA updates guidance on expanded access for investigational drugs under IND

The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
JD Supra

New FDA Approach to Drug Prices Adds Uncertainty to Drug Approval Process

FDA’s focus on playing a direct role in lowering drug prices may provide opportunities for some pharmaceutical companies to seek a regulatory advantage. But it also places enormous pressure on ...
Fierce BiotechOpinion

‘A concerted industry-government effort’: Strand Therapeutics CEO Jake Becraft on FDA’s IND reform and China

For Jake Becraft, Ph.D., the future of America’s biomedical innovation isn’t just playing out in the lab—it's being shaped by ...