miércoles, 15 de enero de 2014

CDER Small Business Update: New Guidances, Notices and Workshops

FDA/CDER's Small Business Assistance

New Guidances, Notices and Workshops

1. Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics  
This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers, packers, and distributors (firms), that may either be the applicant or acting on behalf of the applicant, of prescription human and animal drug and biological products (drugs) can fulfill regulatory requirements for postmarketing submissions of interactive promotional media for their FDA-approved products. This draft guidance clarifies FDA's policies on what the Agency considers to be interactive promotional media.

2. Draft Guidance for Industry on Community-Acquired Bacterial Pneumonia: Developing Drugs for Treatment
The purpose of this draft guidance is to assist clinical trial sponsors and investigators in the development of antibacterial drugs for the treatment of community-acquired bacterial pneumonia (CABP).

3. Draft Guidance for Industry on Qualification of Exacerbations of Chronic Pulmonary Disease Tool for Measurement of Symptoms of Acute Bacterial Exacerbation of Chronic Bronchitis in Patients with Chronic Obstructive Pulmonary Disease
This draft guidance provides a statement of qualification for the Exacerbations of Chronic Pulmonary Disease Tool (EXACT) patient-reported outcome instrument and summarizes the concept of interest and context of use (COU) for which the tool is qualified CDER's drug development tool (DDT) qualification program. This draft guidance is an attachment to the guidance for industry entitled “Qualification Process for Drug Development Tools.”

4. Unapproved and Misbranded Oral and Injectable Drugs Labeled for Prescription Use Containing Codeine Sulfate, Codeine Phosphate, or Dihydrocodeine Bitartrate
FDA is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce.
5. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks in Drug Regulatory Decision-Making; Public Workshop
The purpose of the workshop is to explore potential approaches to addressing and communicating uncertainty, and to identify key considerations on developing, evaluating, and incorporating potential approaches for addressing uncertainty into the assessment of benefits and risks in the human drug review process. The public workshop will be held on February 12, 2014, from 8:30 a.m. to 4:30 p.m. and February 13, 2014, from 8:30 a.m. to 3:30 p.m. at FDA's White Oak Campus in Silver Spring, MD. Registration to attend the public workshop must be received by January 31, 2014.

No hay comentarios: