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FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.[ Price : $8.95]
FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.[ Price : $8.95]
The Washington, DC District Court dismisses a Vanda Pharmaceuticals lawsuit against FDA that challenged the agencys bioequivalence...[ Price : $8.95]
FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocali...[ Price : $8.95]
GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recen...[ Price : $8.95]
FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.[ Price : $8.95]
CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and reg...[ Price : $8.95]
Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformat...