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September 21, 2022

FDA/IMS Joint Workshop: Future of Drug Development in Multiple Myeloma – 11/08/2022

On This Page Date: November 8 – 9, 2022 Day1: Tue, Nov 8 9:00 AM – 3:00 PM ET Day2: Wed, Nov 9 9:00 AM – […]
September 21, 2022

How To Obtain a Covered Product Authorization

Submit Comments by 11/21/2022 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment […]
September 20, 2022

FDA approves sodium thiosulfate to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors

On September 20, 2022, the Food and Drug Administration approved sodium thiosulfate (Pedmark, Fennec Pharmaceuticals Inc.) to reduce the risk of ototoxicity associated with cisplatin in […]
September 20, 2022

How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD

Docket Number: FDA-2014-D-1891 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guidance describes how a prospective abbreviated new drug application (ANDA) applicant […]
September 20, 2022

Drug Supply Chain Security Act Product Tracing Requirements Frequently Asked Questions

The following are common questions and answers about supply chain security requirements of the Drug Supply Chain Security Act. 1. Is the pedigree provision of the […]
September 20, 2022

Salon Technologies, Inc. Issues Voluntary Nationwide Recall of Antica Ocean Citron Hand Sanitizer ( Alcohol ) Gel 65% Due to the Presence of Benzene

Summary Company Announcement Date: September 17, 2022 FDA Publish Date: September 19, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product contains benzene Company […]
September 19, 2022

FDA/IMS Joint Workshop: Future of Drug Development Clinical Drug Development in Multiple Myeloma – 11/08/2022

On This Page Date: November 8 – 9, 2022 Day1: Tue, Nov 8 9:00 AM – 3:00 PM ET Day2: Wed, Nov 9 9:00 AM – […]
September 16, 2022

Developing a Toolkit to Assess Efficacy of Ebola Vaccines and Therapeutics

Image CaptionScientist processing Ebola virus disease samples at Donka Hospital in Conakry, Guinea as part of the EVIDENT project. (Credit: EVIDENT) This project has been completed, […]
September 16, 2022

Voluntary Recall of Certain Colgate Products Sold at Family Dollar Stores Because They Were Stored Outside of Temperature Requirements

Summary Company Announcement Date: September 15, 2022 FDA Publish Date: September 16, 2022 Product Type: Drugs Reason for Announcement: Recall Reason Description Product was stored outside […]
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