Policies - Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies

These policy documents are interpretations of the purpose and intent of the Food and Drugs Act and Regulations. These documents include draft policies out for consultation and final policies.

• Drug/Medical Device Combination Products Policy
  Date: 2005-11-30
• Priority Review of Drug Submissions Policy
  Date: 2005-11-30
• Appeals Procedures for Drug Submissions
  Date: 2003-04-04
• Changes in Manufacturer's Name and/or Product Name
  Date: 2001-01-03
• Issuance of Drug Identification Numbers for New Drugs
  Date: 2000-11-03
• Factors for Listing Drugs in Schedule F
  Date: 1999-08-09
• Inclusion of Women in Clinical Trials during Drug Development
  Date: 1996-09-25
• Policy on Drug/Medical Device Combination Products - Decisions
  Date: 1999-06-07
• Assignment of Drug Identification Numbers (DINs) According to Product Name
  Date: 1998-04-14
• Modified FDA Format Drug Submissions for Products in Human Use
  Date: 1997-10-23
• Assignment of Drug Identification Numbers for Drug Products in Kits
  Date: 1997-07-25
• Orphan Drugs
  Date: 1997-01-16
• Filing of SNDSs, SANDS, NCs and X-REFs
  Date: 1996-05-10
• Labelling of Professional Samples of Drugs
  Date: 1994-02-11
• New Active Substance
  Date: 1991-06-04
• Labelling of Special Containers
  Date: 1990-04-04