The Knowledge Shelf

The results of research studies conducted GDUFA initiatives provide new tools for FDA to evaluate generic drug equivalence.

In accordance with the Generic Drug User Fee Amendments (GDUFA), FDA consults with industry and the public to create an annual list of regulatory science initiatives on generic drugs. These priorities are discussed and developed in public meetings and workshops, resulting in several awarded projects

The Office of Generic Drugs implements the GDUFA Regulatory Science Research Program by collaborating through grants or contracts.

FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Removes Recommended Pause in Use and Approves Required Updated Labeling: FDA Safety Communication

Upcoming EL-PFDD Meetings

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 04/25/2025
Short Title (70 char) Wells Pharmacy Inc. Dyersburg, TN. 483 issued 04/25/2025
FEI Number 3011761321
Firm Name Wells Pharmacy Inc.
Record Type 483
State TN
Establishment Type Outsourcing Facility

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/06/2025
Short Title (70 char) Medi-Fare Drug Pharmaceutical Compounding LLC. Blacksburg, SC. 483 issued 06/06/2025
FEI Number 3009925820
Firm Name Medi-Fare Drug Pharmaceutical Compounding LLC
Record Type 483

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/09/2025
Short Title (70 char) Boothwyn Pharmacy LLC. Kennett Square, PA. 483 issued 06/09/2025
FEI Number 1000076625
Firm Name Boothwyn Pharmacy LLC
Record Type 483
State PA
Establishment Type Producer of Ste

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 05/23/2025
Short Title (70 char) Tailstorm Health Inc dba Medivant Healthcare
FEI Number 3015929581
Firm Name Tailstorm Health Inc
Record Type 483
State AZ
Establishment Type Outsourcing Facility

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/10/2025
Short Title (70 char) MedisourceRx. Los Alamitos, CA. 483 issued 06/10/2025
FEI Number 3013316698
Firm Name MedisourceRx
Record Type 483
State CA

Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 06/13/2025
Short Title (70 char) Pharmcore Inc. dba Hallandale Pharmacy. Fort Lauderdale, FL. 483 issued 06/13/2025
FEI Number 3014480778
Firm Name Pharmcore Inc. dba Hallandale Pharmacy
Record Type 483
State FL

Presidential Emergency Plan for AIDS Relief content