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FDA extends until 4/10/2017 the comment period on its initiative to review Manufacturer Communications Regarding Unapproved Uses o...[ Price : $8.95]
Retiring Office of New Drugs director John Jenkins says CDER is issuing more complete response letters this year, and it is signif...[ Price : $8.95]
FDA and HHS Office for Human Research Protections release a guidance on Use of Electronic Informed Consent (eIC) Questions and An...[ Price : $8.95]
Federal Register Notice: FDA makes available a guidance entitled Public Notification of Emerging Postmarket Medical Device Signals...[ Price : $8.95]
Federal Register Notice: FDA makes available a list of information collections that have been approved by the Office of Management...[ Price : $8.95]
Federal Register Notice: FDA announces a 4/6/2017 public meeting on Patient-Focused Drug Development for Sarcopenia.[ Price : $8.95]
FDA approves an Anacor Pharmaceuticals NDA for Eucrisa (crisaborole) ointment to treat mild to moderate eczema (atopic dermatitis)...[ Price : $8.95]
Stakeholders urge major revisions to an FDA draft guidance on software as a medical device that incorporates an International Medi...