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Guidance on Electronic Informed Consent in Clinical Trials

03/09/2015

Federal Register Notice: FDA is making available a draft guidance for industry, clinical investigators, and institutional review b...

Comments Extended on Drug/Biologic Electronic Prescribing Info

03/09/2015

Federal Register Proposed rule: FDA is extending the comment period until 5/18 for the proposed rule that appeared in the 12/18/14...

Info on IND Regs Sent to OMB

03/03/2015

Federal Register Notice: FDA’s proposed collection of information, “Investigational New Drug (IND) Regulations —...

Workshop on Dystrophin Protein Quantification in Tissue

03/03/2015

Federal Register Notice: FDA and NIH will co-sponsor a public scientific workshop 3/20 to discuss dystrophin protein quantificatio...

Workshop on Pediatric Neurocognitive Outcomes

03/03/2015

Federal Register Notice: CDER’s Division of Gastroenterology and Inborn Errors Products Division and Division of Pediatric a...

Info on Blood CGMPs Sent to OMB

03/03/2015

Federal Register Notice: FDA’s proposed collection of information, “Current Good Manufacturing Practices and Related R...

Guidance on Urinary Tract Infection Treatments

02/17/2015

Federal Register Notice: FDA is making available a guidance for industry entitled Complicated Urinary Tract Infections: Developing...

Clinical Research Associates Conference Planned

02/17/2015

Federal Register Notice: FDA will sponsor the following conference: Educational Conference co-sponsored with the Society of Clinic...

FDA, Xavier Univ. Plan Device Conference

02/17/2015

Federal Register Notice: FDA Cincinnati District and Xavier University will co-sponsor a public conference entitled “FDA/Xav...

Panel to Discuss Superion InterSpinous Spacer

02/17/2015

Federal Register Notice: FDA’s Orthopedic and Rehabilitation Panel of the Medical Devices Advisory Committee will meet 2/20,...