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September 11, 2020

FDA Patient Engagement Opportunities

On this Page: GENERAL: PATIENT ENGAGEMENT OPPORTUNITIES DRUG: PATIENT ENGAGEMENT OPPORTUNITIES Patient-Focused Drug Development (PFDD) DEVICE: PATIENT ENGAGEMENT OPPORTUNITIES Patient Engagement Advisory Committee (PEAC) Patient & […]
September 11, 2020

Learn About FDA Patient Engagement

Patients are at the heart of what the FDA does and are vital to our work protecting the public health by ensuring the safety and efficacy […]
September 11, 2020

FDA Patient Engagement Partnerships

National Organization for Rare Disorder The National Organization for Rare Disorders (NORD) works with individuals with rare diseases and the organizations that serve them. NORD, along […]
September 11, 2020

FDA Patient Engagement Overview*

FDA-led Patient-Focused Drug Development (PFDD) Initiative FDA-led Patient-Focused Drug Development Purpose Public meetings that systematically obtain the patient perspective on specific diseases and their treatments Medical […]
September 10, 2020

Human Drug Compounding

FDA’s Human Drug Compounding Progress Report: Three Years After Enactment of the Drug Quality and Security Act (January 2017)Download PDFText Version Compounding is generally a practice […]
September 10, 2020

Medek, LLC. Issues Voluntary Nationwide Recall of M Hand Sanitizer Due to Potential Presence of Methanol (Wood Alcohol) and Subpotent Ethanol Levels

Summary Company Announcement Date: September 09, 2020 FDA Publish Date: September 10, 2020 Product Type: Drugs Reason for Announcement: Recall Reason Description Contains Methanol and may […]
September 10, 2020

Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

Docket Number: FDA-2020-D-1136 Issued by: Guidance Issuing Office Center for Veterinary Medicine Center for Biologics Evaluation and Research Center for Drug Evaluation and Research FDA plays […]
September 10, 2020

Medication-house.com – 607751 – 09/02/2020

Product: Drugs Recipient: Medication-house.com China Issuing Office: Center for Drug Evaluation and Research | CDER United States DATE: September 2, 2020 WARNING LETTER This is to […]
September 10, 2020

Extrapharma.com – 607931 – 09/02/2020

Product: Drugs Recipient: Extrapharma.com Russia Issuing Office: Center for Drug Evaluation and Research | CDER United States DATE: September 2, 2020 WARNING LETTER This is to […]
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