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CDER Plans Clinical Investigator Training Course

10/03/2012

Federal Register Notice: CDER/Office of Medical Policy and the Duke University Office of Continuing Medical Education are cosponso...

Guidance on Developing Drugs for Chronic Bronchitis in Patients with COPD

10/01/2012

Federal Register Notice: FDA is making available a guidance for industry, Acute Bacterial Exacerbations of Chronic Bronchitis in P...

Comments Sought on Emergency Use Authorization Info

10/01/2012

Federal Register Notice: FDA is seeking comments on the proposed collection of information, “Reporting and Recordkeeping for...

Guidance on Drugs to Treat Intra-Abdominal Infections

10/01/2012

Workshop Slated on Peripheral Neuropathy

10/01/2012

Federal Register Notice: CDER will hold a scientific public workshop 2/11-12/13 to solicit information on a variety of issues rela...

Comments Extended on Antimicrobial New Animal Drugs

09/26/2012

Federal Register Advance notice of proposed rulemaking: FDA is extending the comment period to 11/26 for the 7/27 advance notice o...

FDA Commissioner Delegated Authority on Clinical Trial Info

09/26/2012

Federal Register Notice: The HHS secretary has delegated to the FDA commissioner authority to determine that any clinical trial in...

Panel to Discuss Janssen NDA for TB

09/26/2012

Federal Register Notice: FDA’s Anti-Infective Drugs Advisory Committee will meet 11/28, from 8 a.m. to 5 p.m. at DoubleTree ...

Public Meeting on Patient-Focused Drug Development

09/24/2012

Federal Register Notice: FDA will hold a public meeting 10/25 from 9 a.m. to 12:30 p.m. on the agency’s patient-focused drug...

FDA Seeks Participant Notification for Drug Development Meetings

09/24/2012

Federal Register Notice: FDA is requesting that patient stakeholders notify the agency by 10/3 of their intention to participate i...