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June 30, 2015
The agency gives a limited reprieve to dispensers but requires other trading partners to provide product tracing information.
June 25, 2015
Pharmacy associates say more education regarding the transactional requirements of DSCSA is needed.
June 24, 2015
The agency clarifies its requirements for allowable excess volume and labeled vial fill size in injectables and biologics.
June 19, 2015
The agency takes action against websites that illegally sell unapproved medications.
June 18, 2015
The agency publishes guidance on the physical attributes of generic tablets and capsules.
June 16, 2015
The agency creates initiative to stimulate pediatric drug development.
June 10, 2015
An FDA advisory panel voted 13-3 in favor of approval of Sanofi and Regeneron Pharmaceuticals' cholesterol-homeostasis therapy Praluent (alirocumab).
June 09, 2015
The agency issues draft guidance on the development of drugs to treat Duchenne muscular dystrophy.
June 08, 2015
FDA recently issued a much-anticipated draft guidance on how to define and report established conditions in market applications.
May 29, 2015
The draft guidance document clarifies chemistry, manufacturing, and controls information for marketing applications.