lunes, 5 de mayo de 2014

CDER SBIA Update: New Workshops and Guidance Documents

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry
FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

Workshops and Guidance Documents

1. Public Workshop: Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction

The FDA in co-sponsorship with the National Organization for Rare Disorders (NORD) is announcing a 1-day public workshop. The workshop will provide a forum to discuss the role of immune tolerance induction in patients receiving replacement biological products. 

The workshop will be held on June 9, 2014 from 8:00 am to 5:00 pm at the FDA White Oak in   Silver Spring, MD 20993.

Additional information                                          
2. Pediatric Clinical Investigator Training Workshop
FDA’s Office of Pediatric Therapeutics (OPT) and the Center for Drug Evaluation and Research are announcing a 1-day public workshop entitled “Pediatric Clinical Investigator Training.” The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling.
The public workshop will be held on September 22, 2014, from 8 a.m. to 5:30 p.m. at the Pooks Hill Marriott, 5151 Pooks Hill Rd., Bethesda, MD 20814.
3. Guidance for Industry: Interpreting Sameness of Monoclonal Antibody Products Under the Orphan Drug Regulations 
The purpose of this guidance is to provide sponsors and manufacturers FDA's current thinking on the criteria by which two monoclonal antibody products would be considered the same under the Orphan Drug Act and implementing regulations.

4. Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports

This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports.

5. Draft Guidance for Industry: Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs

This guidance discusses how applicants for low molecular weight heparin (LMWH) products should provide information on impurities and the potential impact on immunogenicity.

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