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Stakeholders express concerns about an FDA draft guidance on biologic naming.[ Price : $8.95]
A Kaiser Family Foundation health tracking poll finds that people think drug companies spend too much on advertising to patients a...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on an information collection on investigational device exemptions reports and records.[ Price : $8.95]
The CDER Office of Generic Drugs issues a MAPP with the process for reviewing and approving or denying requests for consolidation ...[ Price : $8.95]
Cubist asks FDA to impose specific bioequivalence requirements on ANDA and 505(b)(2) NDA applicants citing Dificid as the referenc...[ Price : $8.95]
CDER says that a main fundamental goal for negotiating the Generic Drug User Fee Act reauthorization will be to align with Industr...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Aros Surgical Instruments and SSM Health Care dba SSM St. Clare Health Center.[ Price : $8.95]
FDA finalizes a guidance on product development under the Animal Rule when human efficacy studies are not ethical or feasible.