July 14, 2022

Investigational New Drug Submissions for Individualized Antisense Oligonucleotide Drug Products for Severely Debilitating or Life-Threatening Diseases: Chemistry, Manufacturing, and Controls Recommendations Guidance for Sponsor-Investigators

Docket Number: FDA-2021-D-1139 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing […]
July 14, 2022

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

Docket Number: FDA-2019-D-1615 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research This guidance provides recommendations for developing the content and format of a […]
July 14, 2022

Lewiston Feed & Produce Company – 613123 – 09/15/2021

Delivery Method: VIA UPS Product: Animal & VeterinaryDrugs Recipient: Recipient Name Steven R. Kanz Recipient Title President Lewiston Feed & Produce Company 105 E. Main StreetLewiston, […]
July 14, 2022

Hawaii Health Systems Corporation dba Kona Community Hospital Pharmacy – 611130 – 06/27/2022

Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Clayton McGhan, MHA Recipient Title Interim West Hawaii Regional CEO Hawaii Health Systems Corporation dba […]
July 13, 2022

Hospira Issues a Voluntary Nationwide Recall for One Lot of Propofol Injectable Emulsion, USP (Containing Benzyl Alcohol), Due to the Potential Presence of Visible Particulate

Summary Company Announcement Date: July 13, 2022 FDA Publish Date: July 13, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Potential presence of visible […]
July 13, 2022

Expanded Access (Compassionate Use) Submission Data

CDER, CBER and CDRH Expanded Access INDs and Protocols (2016-2020) On this page you will find: The Center for Drug Evaluation and Research (CDER) and the […]
July 13, 2022

Mitigating Risks of Compounded Drugs Through Surveillance

FDA’s Compounding Incidents Program aims to help protect the public against poor quality compounded drugs through surveillance and review of complaints, which include adverse event and […]
July 13, 2022

Meeting Presentations | Drugs

CDER professionals participate in several meetings, conferences and workshops throughout the year. Appealing primarily to the pharmaceutical industry and health care professionals, topics can range from users […]
July 12, 2022

Caution Consumers:

Image Don’t Fall for False Claims When you’re browsing, one of the best ways to protect yourself from fake, and even possibly harmful, products is asking […]
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