Tag: New Drug Application

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Recent Related Articles to New Drug Application

FDA Issues Latest Draft Guidance on the Use of Real-World Data - National Law Review

Added to Collection on: 2021-12-28 18:55:41

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Food and Drug Administration
Clinical research
Health
Medical research
Drug safety
Evidence
Health informatics
Real world data
New Drug Application
Investigational New Drug
Real World Evidence
Michael R. Taylor
u.s. food and drug administration

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Korea's Samsung Bio reveals massive capacity boost on the cards - BioPharma Reporter

Added to Collection on: 2022-01-13 16:49:07

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Life Sciences
Pharmaceutical industry
Health sciences
Biotechnology
Food and Drug Administration
Drug safety
Biopharmaceutical
Pharmacy
Samsung
New Drug Application
Biologics license application
GenScript Biotech

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Roche gets FDA priority review for Evrysdi to treat SMA in new-borns

Added to Collection on: 2022-01-27 11:17:19

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Spinal muscular atrophy
Neurological disorders
Drugs
Orphan drugs
Health sciences
Risdiplam
PTC Therapeutics
SMA
New Drug Application
SMA Foundation

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CORTEXYME ALERT: Bragar Eagel & Squire, P.C. is Investigating Cortexyme, Inc. on Behalf ...

Added to Collection on: 2022-02-25 03:10:57

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Drug safety
Food and Drug Administration
Health sciences
Health
Life Sciences
Gingipain
Proteases
Porphyromonas gingivalis
CRTX
Investigational New Drug
New Drug Application

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Regulatory recap: J&J vaccine limits, full Enhertu approval, a Vertex hold & more - MedCity News

Added to Collection on: 2022-05-08 21:30:39

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Life Sciences
Health sciences
Health care
Food and Drug Administration
Pharmaceutical industry
Drug safety
Drug discovery
Clinical research
New Drug Application
Drug development
Investigational New Drug
Janssen COVID-19 vaccine
Johnson & Johnson
BioNTech
Moderna
Pfizer

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Food and Drug Amendments of 2022 (PDUFA VII) | Alston & Bird - JDSupra

Added to Collection on: 2022-06-15 18:47:36

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Food and Drug Administration
Health sciences
Health
Prescription Drug User Fee Act
Good manufacturing practice
New Drug Application
Clinical trial
Dietary supplement
FDA Center for Devices and Radiological Health
Medical device
Food and Drug Administration Modernization Act
PDUFA date

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Minerva Neurosciences (NERV) Stock: Why It Dropped 69.55% - Pulse 2.0

Added to Collection on: 2022-10-18 13:02:29

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Health
Food and Drug Administration
Drug safety
Articles
Kakao
Minerva
New Drug Application
Minerva Neurosciences

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New FDA Reform Legislation: Congress Gifts a “FDORA” for the Holidays

Added to Collection on: 2023-01-09 16:34:07

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Health
Articles
Food and Drug Administration
Pharmaceuticals policy
Food law
Pharmaceutical industry
Pharmacy
Federal Food, Drug, and Cosmetic Act
New Drug Application
Biosimilar
Compounding
Medical device
United States

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FTC Employs New Tactic in Effort Against Drug… | Fenwick & West LLP

Added to Collection on: 2023-11-16 18:07:25

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Pharmaceutical industry
Food and Drug Administration
Biotechnology products
Drug safety
Approved Drug Products with Therapeutic Equivalence Evaluations
New Drug Application
Generic drug
Approved drug
Patent
FTC v. Actavis, Inc.
Term of patent in the United States

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FDA Issues Draft Guidance on Its New Platform Technology Designation Program

Added to Collection on: 2024-06-12 17:22:48

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Food and Drug Administration
Biotechnology products
Drug safety
Drug development
Clinical research
New Drug Application
Center for Biologics Evaluation and Research
Biologics license application
Investigational New Drug
Biopharmaceutical
Approved drug
Fast track

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