Tag: New Drug Application

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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FDA Issues Draft Guidance on Its New Platform Technology Designation Program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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Insights on MHRA's International Recognition Procedure - Pharmacy Times

Added to Collection on: 2024-07-04 15:59:55

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Drug safety
Pharmaceutical industry
Biotechnology products
Food and Drug Administration
Drug development
Medicines and Healthcare products Regulatory Agency
Electronic common technical document
Human Medicines (Coronavirus and Influenza) (Amendment) Regulations
Marketing authorisation
New Drug Application
MHRA
Medication
United Kingdom

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FDA accepts UroGen's UGN-102 NDA for bladder cancer treatment

Added to Collection on: 2024-10-16 17:02:36

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Bladder cancer
Food and Drug Administration
New Drug Application
Nogapendekin alfa inbakicept

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FDA Regulatory Compliance for Drug and Biotech Product - GlobeNewswire

Added to Collection on: 2024-11-08 10:11:22

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Food and Drug Administration
Pharmaceuticals policy
Food law
Form FDA 483
Regulatory affairs
Federal Food, Drug, and Cosmetic Act
Biosimilar
Good manufacturing practice
Pharmaceutical industry in China
Center for Drug Evaluation and Research
New Drug Application

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Biopharmaceutical Company's Stock Plunges 75% After FDA Rejects New Drug - Inkl

Added to Collection on: 2024-11-30 00:18:13

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Food and Drug Administration
Drug development
Govorestat
Pyridazines
Thienopyridines
Complete Response Letter
Galactosemia
New Drug Application
applied therapeutics
Getty Images

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RAI Explainer: Generic Drugs, Property Rights, and the Orange Book - CSIS

Added to Collection on: 2024-12-04 18:18:58

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Food and Drug Administration
Pharmaceuticals policy
Drug pricing
Pharmaceutical industry
Pharmacy
Generic drug
Abbreviated New Drug Application
Approved Drug Products with Therapeutic Equivalence Evaluations
Drug Price Competition and Patent Term Restoration Act
Medication costs
Medication
New Drug Application
United States

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Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient

Added to Collection on: 2025-01-20 23:17:37

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Food and Drug Administration
Generic drug
Pharmaceutical industry
Pharmaceuticals policy
Public domain
Abbreviated New Drug Application
Approved Drug Products with Therapeutic Equivalence Evaluations
Teva Pharmaceuticals
Patent infringement
Drug Price Competition and Patent Term Restoration Act
New Drug Application
Patent
albuterol sulfate
Amneal Pharmaceuticals
Teva

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