fbpx
May 22, 2020

Regulatory Education for Industry: Advancing Innovative Science in Generic Drug Development Workshop – 09/29/2020 – 09/30/2020

On This Page Date: September 29 – 30, 2020 Time: 8:00 AM – 4:30 PM ET Regulatory Education for Industry: Advancing Innovative Science in Generic Drug […]
May 22, 2020

PharMEDium Services Issues Voluntary Nationwide Recall of Specific Lots of Potassium Phosphate and Succinylcholine Chloride Due to a Lack of Sterility Assurance

Summary Company Announcement Date: June 25, 2017 FDA Publish Date: February 07, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Due to Lack of […]
May 22, 2020

North Coast Biologics – 607532 – 05/21/2020

Product: BiologicsDrugs Recipient: Recipient Name Johnny T. Stine North Coast Biologics 4025 Stone Way NSeattle, WA 98103United States [email protected] Date:   May 21, 2020 RE:     Unapproved […]
May 21, 2020

Les Produits Chimiques B.G.R., Inc. – 542247 – 05/21/2020

Reference #: 320-18-64 Product: Drugs Recipient: Recipient Name Ms. Nathalie A. Bélanger Recipient Title Vice-President and Owner Les Produits Chimiques B.G.R., Inc. 600 Avenue DelmarPointe-Claire QC […]
May 21, 2020

Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA) – 07/23/2020 – 07/23/2020

On This Page Date: July 23, 2020 Time: 9:00 AM – 2:00 PM ET The Food and Drug Administration (FDA or Agency) is announcing a virtual […]
May 21, 2020

PDUFA VII: Fiscal Years 2023 – 2027

In August 2017, the FDA Reauthorization Act of 2017 (FDARA) was enacted, which renewed the prescription drug user fee program (PDUFA) for a sixth time. The […]
May 21, 2020

DDT COA #2019-01: PostopQRS

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Neuroscience (ON)Division of Anesthesia, Addiction Medicine, and Pain Medicine (DAAP) DDT COA NumberDDT COA #2019-01 Instrument NamePostopQRS Disease/ConditionRecovery from […]
May 21, 2020

DDT COA #000053: Symbol Digit Modalities Test (SDMT)

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Neuroscience (ON)Division of Neurology II (DN II) DDT COA NumberDDT COA #000053 Instrument NameSymbol Digit Modalities Test (SDMT) Disease/ConditionMultiple […]
May 21, 2020

DDT COA #000069: Fatigue PRO in Multiple Sclerosis

Clinical Outcome Assessments (COA) Qualification SubmissionsOffice of Neuroscience (ON)Division of Neurology II (DN II) DDT COA NumberDDT COA #000069 Instrument NameFatigue PRO in Multiple Sclerosis Disease/ConditionMultiple […]
google.com, pub-5711488453051849, DIRECT, f08c47fec0942fa0