Human Drugs
FDA Releases Sun Form 483 After Latest Inspection in India
FDA cites Sun Pharmaceuticals with an 11-item Form 483 after completing a week-long inspection 4/13 at the firms Dadra, India finished-dosage drug man...
Federal Register
Science Board to Review Innovation Funds Work Plan
Federal Register notice: FDA announces a 5/9 Science Board meeting that is intended to provide recommendations on the agencys Innovation Funds work pl...
Human Drugs
Since Our Last Issue ...
Industry news you may have missed since our last issue.
FDA General
Latest Federal Register Notices
FDA Review posts the Federal Register notices for the week ending 4/21/2017.
Medical Devices
Class 1 Recall of Medtronic StrataMR Valves and Shunts
FDA classifies as Class 1 a Medtronic recent recall of all unused units of the StrataMR adjustable valves and shunts due to an increase in product com...
Human Drugs
FDA Issues a Complete Response Letter on Vernalis NDA
FDA issues Vernalis a complete response letter for CCP-07, an extended release equivalent product to an undisclosed prescription cough-cold treatment.
Federal Register
Comments Sought on FDAs Focus Group Use
Federal Register notice: FDA seeks comments on an information collection on Focus Groups as Used by the Food and Drug Administration (all FDA- regulat...
Human Drugs
Draft Guide on Generic Narcan Bioequivalence Studies
FDA posts a draft guidance on generic naloxone hydrochloride nasal spray entitled Draft Guidance on Naloxone Hydrochloride.
Human Drugs
FDA Agrees to 2 Special Protocols for Basilea Antibiotic
FDA and Basilea Pharmaceutica reach agreement on Special Protocol Assessments (SPAs) for two planned Phase 3 clinical studies evaluating the companys ...
Human Drugs
Bill Introduced to Speed Drug Approval After EU Action
Rep. Steve Stivers (R-OH) reintroduces the Speeding Access to Already Approved Pharmaceuticals Act that would require FDA to expedite the review of ph...
