FDA says research it funded demonstrated that in two contexts shorter courses of antibiotic treatment were as effective as longer courses, reducing th...
The Consumer Healthcare Product Association recommends four steps FDA should take in implementing an appeals court decision on regulating drug/device ...
FDA warns Adamson Analytical Laboratories about repeat CGMP violations in its work as a contract testing laboratory.
FDA Office of Regulatory Affairs assistant commissioner Elizabeth Miller tells an industry conference that her office has embraced the flexibility and...
Yale University researchers say giving sponsors extended periods to complete post-accelerated approval studies may not be justified.
New research uncovers numerous software vulnerabilities in medical devices.
Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances that provide product-specific recommendatio...
Federal Register notice: FDA sends to OMB an information collection extension entitled MedWatch: The FDA Medical Products Reporting Program.