September 13, 2022

Texas Longhorn RX, LLC – 639220 – 08/29/2022

Product: Drugs Recipient: Recipient Name Praful Patel Recipient Title Co-Owner Texas Longhorn RX, LLC 5900 Balcones Dr, STE 100Austin, TX 78731United States Issuing Office: Office of […]
September 12, 2022

Generic Competition and Drug Prices

How Generic Competition Helps Bring Down Drug Prices Access to affordable medicines remains a significant public health priority for FDA. The agency regularly conducts economic analyses […]
September 12, 2022

Amneal Pharmaceuticals Issues Voluntary Nationwide Recall of Lorazepam Oral Concentrate, USP 2mg/mL, Due to Misprinted Dosing Droppers Supplied with the Product

Summary Company Announcement Date: August 14, 2017 FDA Publish Date: February 08, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Misprinted Dosing […]
September 12, 2022

Emergency Use Authorization of Medical Products and Related Authorities

Docket Number: FDA-2016-D-1025 Issued by: Guidance Issuing Office Office of the Commissioner, Office of the Chief Scientist, Office of Counterterrorism and Emerging Threats Guidance for Industry […]
September 9, 2022

Endpoint Considerations to Facilitate Drug Development for Niemann-Pick Type C (NPC) Public Workshop – 01/24/2022

On This Page Date: January 24 – 25, 2022 Time: 12:00 PM – 3:30 PM ET Date: January 24-25, 2022   Background and Meeting Objectives Niemann-Pick […]
September 8, 2022

Registered Outsourcing Facilities

Facility Name Contact Name and Phone Number Initial Date of Registration as an Outsourcing Facility1 Date of Most Recent Registration as an Outsourcing Facility1 End Date […]
September 8, 2022

Real-World Evidence

Real-world data (RWD) and real-world evidence (RWE) are playing an increasing role in health care decisions. FDA uses RWD and RWE to monitor postmarket safety and […]
September 8, 2022

Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products

Docket Number: FDA-2019-D-1263 Issued by: Guidance Issuing Office Oncology Center of Excellence To facilitate FDA’s internal tracking of submissions to the Agency that include real-world data […]
September 8, 2022

FDA draft guidance aims to improve consistency of labeling for nonprescription drugs

[9/8/2022] FDA announced the availability of a draft guidance titled “Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products,” […]
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