Some 165 healthcare-related organizations urge Congress to pass the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance Act before the ...
ECA Academy lists the top 10 GMP observations from 42 Warning Letters issued in FY 2022.
Federal Register notice: FDA issues an order debarring David Elias Mendoza for five years from importing or offering for import any drug into the U.S.
FDA says MITRE has updated a 2018 playbook explaining how healthcare organizations can prepare for and respond to cybersecurity incidents.
FDA is soliciting comments on a preliminary assessment that some naloxone products may be safe and effective when sold over-the-counter.
FDA medical reviewers ask the Cardiovascular and Renal Drugs Advisory Committee to consider whether the benefits of Ardelyx tenapanor outweigh its ris...
FDA announces a 12/7 public workshop on Appropriate Use of Consensus Standards to obtain public input on using these in premarket submissions for medi...
FDA releases the form FDA-483 issued following an inspection at the Clarence, NY-based Athenex Pharma Solutions outsourcing facility.