FDA Lists Guidance Documents Planned for 2013 - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

FDA Lists Guidance Documents Planned for 2013


ePT--the Electronic Newsletter of Pharmaceutical Technology

FDA has released a list of more than 50 guidance documents planned for 2013.  The list reflects guidance documents currently under development as of the date of the posting, Jan. 31, 2013. Planned documents relevant to cGMP and compliance include: 

  • Quality Systems Approach to Pharmaceutical cGMP Regulation (OMPQ)
  • Uniformity of In-Process Mixtures (OMPQ)
  • Control of Highly Potent Compounds (OMPQ)
  • Contract Manufacturing Arrangements for Drugs: Quality Agreements
  • Submission of Field Alert Reports and Biological Product Deviation Reports (OMPQ)
  • Pre-Launch Activities Importation Request (PLAIR)

With regards to biosimilars, the agency plans a guidance on Submission of Clinical Pharmacology Data as Evidence of Biosimilarity for Biologics and Protein Products, as well as one titled Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants.

Other guidance documents in the planning stage include Securing the Drug Supply Chain—Standards for Tracking and Tracing Prescription Drug Packages, and a guidance on compounded medications titled Pharmacy Compounding of Human Drugs Under Section 503A of the Federal Food, Drug, and Cosmetic Act.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
31%
Breakthrough designations
8%
Protecting the supply chain
42%
Expedited reviews of drug submissions
8%
More stakeholder involvement
12%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Sandoz Wins Biosimilar Filing Race
NIH Translational Research Partnership Yields Promising Therapy
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here