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CDERs Office of Prescription Drug Promotion says that a Celgene TV ad for Otezla undermines communication of important risk inform...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Pocono Coated Products and United Contact Lens.[ Price : $8.95]
President Obama signs into law the 21st Century Cures Act, which will provide a $500 million funding boost for FDA over the next 1...[ Price : $8.95]
FDA selects Department of Justice Office of International Affairs attorney Donald D. Ashley as CDERs next Office of Compliance dir...[ Price : $8.95]
FDA finalizes a guidance on Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals) that describes CD...[ Price : $8.95]
A CDRH conference call clarifies when medical device firms are required to file Medical Device Reporting submissions and answers q...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a new information collection related to Donor Risk Assessment Questionnaire for FDA...[ Price : $8.95]
Federal Register Notice: FDA determines the regulatory review period for patent extension purposes of GlaxoSmithKlines Nucala (mep...