CDRH issues an alert on AVID Medical convenience kits based on a letter the company sent to customers recommending that certain kits be corrected prio...
A Friends of Cancer Research white paper recommends a new approach to support administered activity escalation and dosage optimization in developing r...
CBER publishes a Standard Operating Policy and Procedure resource on complying with provisions of the Pediatric Research Equity Act and the Best Pharm...
Four stakeholders recommend ways FDA can improve a draft guidance on leveraging prior knowledge in developing some human gene therapy products.
FDA releases a draft guidance entitled Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosage.
FDA warns Fresenius Medical Care North America about CGMP violations at its Ogden, UT, drug manufacturing facility.
FDA posts two guidance documents on dental composite resins and curing lights.
FDA warns Indias Reliance Life Sciences about significant CGMP violations in its production of finished drugs.
