FDA Approvals - Wary FDA, Others Taking Time With Drug Reviews (TheStreet.com) Fitch
Wary FDA, Others Taking Time With Drug Reviews (TheStreet.com)
Fitch Ratings says new drug applications faced longer review periods at the FDA and other regulatory agencies during the third quarter, creating a logjam of potential approvals.
FDA Grants NeoVista's Request To Utilize Novel Wet AMD Treatment In Compassionate Case (Medical News Today)
NeoVista, Inc., announced that the U.S. Food and Drug Administration (FDA) had approved the company's "compassionate case" waiver to utilize its novel wet age-related macular degeneration (AMD) treatment on a patient with an advanced form of the disease who did not meet criteria for inclusion into current NeoVista investigational treatment protocols.
Despite FDA Suicide Warning Epilepsy Experts Urge Patients And Caregivers To Continue Drug Therapy (Medical News Today)
Medical specialists at the nation's largest professional meeting on epilepsy discussed multiple questions and concerns they have about data presented by the FDA in support of its recent suicide alert on anticonvulsant drugs (AEDs) and the potential effect of the federal agency's analyses on clinical practice and the way AED drug trials are to be conducted in the future.