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FDA solicits comment on a draft guidance to assist drug sponsors and medical device manufacturers who want to coordinate developme...[ Price : $8.95]
FDA issues a guidance on reporting formats for medical device computational modeling and simulation studies.[ Price : $8.95]
Alcon calls on FDA to eliminate the in vitro option for bioequivalence testing for generic Durezol.[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Option Care Enterprises, Jeffreys Drug Store, Sarkli/Repechage and ZO Skin Healt...[ Price : $8.95]
KemPharm decides to file a formal dispute resolution challenge to an FDA rejection of its claim of abuse deterrence for the labeli...[ Price : $8.95]
FDA approves a Med-El USA PMA for the Synchrony EAS (Electric Acoustic Stimulation) Hearing Implant System.[ Price : $8.95]
FDA announces a Naloxone App Competition, a public contest focused on developing a mobile phone application that can connect opioi...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of contr...