Vaccines, Blood & Biologics
-
?
-
Industry (Biologics)
The Center for Biologics Evaluation and Research (CBER) has established a Manufacturers Assistance and Technical Training 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.
-
Laws, Regulations, Guidances and Other Information
Biologics Guidances Biologics Procedures (SOPPs) Biologics Rules - Biosimilar User Fee Act of 2012
Biosimilars Dockets Management Federal Food, Drug, and Cosmetic Act (FD&C Act) Federal Register (FR) Notices Food and Drug Administration Safety and Innovation Act (FDASIA) Generic Drug User Fee Amendments of 2012 Guidances Information about MDUFA III Memoranda to Blood Establishments Other Laws Affecting FDA PDUFA V: Fiscal Years 2013 - 2017 Rules & Regulations
-
-
Establishment Registration
-
-
-
-
Product Application and Approval
Biologics License Applications (BLA) Process (CBER) Premarket Approval (PMA) Process (CBER) New Drug Application (NDA) Process (CBER) 510(k) Process (CBER) Advertising & Labeling (Biologics) Manufacturers Assistance (CBER) U.S. Food and Drug Administration Statement: The impact of February’s inclement weather on Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee Act (MDUFA) deadlines
-
-
Postmarketing, Compliance and Enforcement
Biologics Post-Market Activities Biologic Product Security Biologic Product Shortages Compliance Programs (CBER) Impact of Severe Weather Conditions on Biological Products Importing & Exporting (Biologics) Lot Distribution Database (LDD) Product Surveillance (CBER) Recalls (Biologics) Report a Problem to the Center for Biologics Evaluation & Research Direct Recall Classification Program Safety & Availability (Biologics) Untitled Letters (CBER)
-
?
-
-
