Industry
The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance Branch to provide assistance and training to industry, including large and small manufacturers and trade associations, and to respond to requests for information regarding CBER policies and procedures. Manufacturers assistance is available in numerous areas including: clinical investigator information, adverse event reporting procedures, electronic submissions guidance and requirements, and information on how to submit an Investigational New Drug Application (IND) to administer an investigational product to humans.
If you have questions or are unable to find the information you need, please contact:*
Center for Biologics Evaluation and Research
Office of Communication, Training & Manufacturers Assistance
Division of Manufacturers Assistance and Training
Manufacturers Assistance and Technical Training Branch
800-835-4709 or 301-827-1800
matt@fda.hhs.gov
*Please choose one method of contacting us.
CBER is reannouncing the invitation for participation in its Regulatory Site Visit Training Program (RSVP). This training program is intended to give CBER regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities. These visits are intended to allow CBER staff to directly observe routine manufacturing practices and to give CBER staff a better understanding of the biologics industry, including its challenges and operations. Submit a written or electronic request for participation in this program by February 21, 2008. See the Federal Register Notice "Regulatory Site Visit Training Program" for further information.
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Action Plans
Acts & Regulations
- Laws Enforced by the FDA and Related Statutes
- Code of Federal Regulations (CFR) - Biologics Related
- FDA Modernization Act of 1997 (FDAMA)
- Food and Drug Administration Amendments Act of 2007 (FDAAA)
- Medical Device User Fee and Modernization Act of 2002 (MDUFMA)
- Prescription Drug Marketing Act (PDMA)
- Prescription Drug User Fee Act (PDUFA)
- Public Health Service Act
- Adverse Event Reporting
- Impact of Severe Weather Conditions on Biological Products
- Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE) Letters
Guidances, Rules, and Standard Operating Procedures
- Guidances, Guidelines, Points to Consider
- Manual of Regulatory Standard Operating Procedures and Policies (SOPPs)
- Rules
Import & Export
- Compliance Program Guidance Manual: 7342.007 - Imported CBER-Regulated Products
- Export Certificates
- Importing Antivenom
- Importing Samples for Research Use Only
Product Development and Application Submission
- Applications for Approval to Market a New Drug; Complete Response Letter; Amendments to Unapproved Applications - Federal Regiser - 7/10/2008
- Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions; Correction - Federal Register - 12/26/2007
- FDA Form 3674 - Certification of Compliance, under 42 U.S.C. , 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C., 282(j)) (PDF - 847 KB)
- Agency Emergency Processing Under the Office of Management and Budget Review; Certification to Accompany Drug, Biological Product, and Device Applications or Submissions - Federal Register - 12/12/2007
- Federal Register Notice: New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule - 5/31/2002 (aka Animal Rule)
- Clinical Investigator Information
- Combination Products
- Critical Path Initiative
- Device Applications
- Electronic Submissions
- Investigational New Drug Application (IND) Submission
- Electronic IND (eIND)
- References for the Regulatory Process for the Office of Cellular, Tissue and Gene Therapies
- Lot Distrbution Data (LDD) Electronic Submssion
- Pediatrics
- Postmarketing Commitments
- Transfer of Therapeutic Products to CDER
- User Fee Billable Products
- The Evolution of Drug Master Files (DMFs) - Drug Information Association Webinar - 3/19/2007
- Drug Master Files - CBER Processes and Review (PDF - 156 KB) - Jay Eltermann, R.Ph., M.S.