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May 7, 2021

List of Determinations Including Written Request

Drug Sponsor Determination Date Written Request and Related Documents Abatacept   BMS 2/14/2017  Acetaminophen Mallinckrodt 7/11/2016 Albuterol GlaxoSmithKline 8/27/2008 Alfuzosin Sanofi Aventis 9/7/2010 Aliskiren Noden Pharma DAC […]
May 6, 2021

DDT COA #000148: Diary for Irritable Bowel Syndrome Symptoms- Diarrhea (DIBSS-D)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Immunology and Inflammation (OII)Division of Gastroenterology (DG) DDT COA NumberDDT COA #000148 Instrument NameDiary for Irritable Bowel Syndrome Symptoms- […]
May 6, 2021

Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions – 06/07/2021 – 06/08/2021

On This Page Date: June 7 – 8, 2021 Time: 9:00 AM – 5:00 PM ET DESCRIPTION/SUMMARY The public workshop will be held virtually. The Food […]
May 6, 2021

Public Notification: Ginseng Power 5000 contains hidden drug ingredient

[05-06-2021] Update: This product has been recalled by NS NY Distributor Inc. See the company’s press release for more information on the recall. This product was sold by NS […]
May 6, 2021

Public Notification: Premium OrgaZen 7000 contains hidden drug ingredients

[05-06-2021] Update: This product has been recalled by NS NY Distributor Inc. See the company’s press release for more information on the recall. This product was sold by NS […]
May 5, 2021

FDASIA Section 705 Annual Reports

Annual Reports on Inspections of EstablishmentsSection 705 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requires FDA to publish annual reports on its website […]
May 5, 2021

FDA grants accelerated approval to pembrolizumab for HER2-positive gastric cancer

On May 5, 2021, the Food and Drug Administration granted accelerated approval to pembrolizumab (Keytruda, Merck & Co.) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy […]
May 5, 2021

Coronavirus (COVID-19) Update: FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

For Immediate Release: May 05, 2021 Today, the U.S. Food and Drug Administration issued a new report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the […]
May 4, 2021

Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate

Summary Company Announcement Date: May 04, 2021 FDA Publish Date: May 04, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to visible particulate […]
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