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May 12, 2020

Is It Really ‘FDA Approved?’

Español “FDA approved!” Maybe you saw those words on a company’s website, or in a commercial promoting a new product or treatment. Some marketers may say […]
May 12, 2020

Qualified Clinical Outcome Assessments (COA)

The table below lists qualified Clinical Outcome Assessments (COA). The tables include legacy projects (those submitted prior to passage of the 21st Century Cures Act), as […]
May 12, 2020

Oncologic Drugs Advisory Committee Roster

Jaffer A. Ajani, MDExpertise: Medical OncologyTerm: 7/1/2019 – 6/30/2023Professor, Department of Gastrointestinal Medical Oncology, Division of Cancer MedicineProfessor, Department of Epidemiology, Divisionof Office of the Vice […]
May 12, 2020

Drug Trials Snapshots: ONGENTYS

HOW TO USE THIS SNAPSHOTThe information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether […]
May 12, 2020

Clinical Outcome Assessments (COA) Qualification Submissions Program

The tables below list information about submissions to the FDA Clinical Outcome Assessments (COA) Qualification Program for which final COA qualification determinations have not yet been […]
May 12, 2020

Warning Letters 2020

Plum Dragon Herbs, Inc. Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) 5/8/2020 Seanjari Preeti Womb Healing, L.L.C. Unapproved and Misbranded Products Related to […]
May 12, 2020

DDT COA #000003: Exacerbations of Chronic Pulmonary Disease Tool (EXACT)

Qualified Clinical Outcome Assessments (COA)Office of Infectious Diseases (OID)Division of Anti-Infectives (DAI) DDT COA NumberDDT COA #000003 Instrument NameExacerbations of Chronic Pulmonary Disease Tool (EXACT) Disease/ConditionAcute […]
May 12, 2020

Mylan Pharmaceuticals Inc. – 557903 – 05/11/2020

Product: Drugs Recipient: Recipient Name Ms. Heather Bresch Recipient Title Chief Executive Officer Mylan Pharmaceuticals Inc. 1000 Mylan BoulevardCanonsburg, PA 15317United States Issuing Office: Office of […]
May 12, 2020

Techni Med, Inc. dba The Compounder – 493750 – 05/05/2020

Delivery Method: UPS Next Day Reference #: CHI-10-16 Product: Drugs Recipient: Recipient Name Lawrence J. Frieders Recipient Title Owner and Pharmacist in Charge Techni Med, Inc. […]
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