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May 12, 2020

Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency

On this page CDER is committed to supporting the development of novel drugs, and the potential repurposing of existing therapies, to address the Coronavirus Disease 2019 […]
May 11, 2020

Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19

For Immediate Release: May 11, 2020 Today, the U.S. Food and Drug Administration took important actions to help accelerate the development of prevention and treatment options […]
May 11, 2020

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Docket Number: FDA-2020-D-1370 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research FDA plays a critical role in […]
May 11, 2020

Coronavirus (COVID-19) Update: Daily Roundup May 11, 2020

For Immediate Release: May 11, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
May 11, 2020

COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research FDA plays a critical role in protecting the United […]
May 11, 2020

MasterPharm, LLC. Issues Voluntary Nationwide Recall of Finasteride Plus 1.25mg Due to the Presence of an Undeclared Antihypertensive Drug

Summary Company Announcement Date: May 06, 2020 FDA Publish Date: May 11, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains undeclared minoxidil Company […]
May 11, 2020

Background Information: List of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book)

Why are there two Purple Books? The “Purple Book” began as two lists (one for the CDER and one for CBER) that kept track of each […]
May 11, 2020

FDA approves olaparib plus bevacizumab as maintenance treatment for ovarian, fallopian tube, or primary peritoneal cancers

On May 8, 2020, the Food and Drug Administration expanded the indication of olaparib (LYNPARZA, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line […]
May 11, 2020

Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research [Updated 5/11/2020] FDA plays a critical role in protecting the United States […]
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