Tag: New Drug Application

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Recent Related Articles to New Drug Application

United States: CBD Regulation: Recent FDA Enforcement Casts A Wider Net Over CBD Products

Added to Collection on: 2021-05-06 14:48:45

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Health care
Health
Food and Drug Administration
Drugs
Pharmaceuticals policy
Drug safety
Food law
Cannabidiol
Cannabinoids
Over-the-counter drug
Federal Food, Drug, and Cosmetic Act
New Drug Application
u.s. food and drug administration

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Demeetra AgBio Advances Major Pipeline for Therapeutic Cannabinoid Development; Invites ...

Added to Collection on: 2021-06-16 18:45:00

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Health care
Health
Pharmaceutical industry
Food and Drug Administration
United States Public Health Service
New Drug Application
Arcturus Therapeutics
Demeetra AgBio Inc.

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External controls can augment low populations in rare disease trials

Added to Collection on: 2023-11-27 15:56:39

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Pharmaceutical industry
Food and Drug Administration
Clinical research
Drug discovery
Design of experiments
Clinical trial
Belimumab
New Drug Application
GSK plc
Drug development
Shutterstock

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Goldman Sachs maintains 'neutral' on Dynavax with $20 target - Investing.com

Added to Collection on: 2024-05-14 19:52:42

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Food and Drug Administration
Drug development
Biotechnology products
Regulation
Complete Response Letter
CRL
Goldman Sachs
New Drug Application
Hemodialysis
Biopharmaceutical
Dynavax
u.s. food and drug administration

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FDA Issues Draft Guidance on Its New Platform Technology Designation Program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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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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FDA Finalizes Guidance on Predetermined Change Control Plans for AI-Enabled Medical ...

Added to Collection on: 2024-12-11 20:49:43

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Food and Drug Administration
FDA Center for Devices and Radiological Health
Medical device
New Drug Application
u.s. food and drug administration

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FDA Announces Plan to Phase Out Animal Testing Requirement | Insights | Holland & Knight

Added to Collection on: 2025-04-15 18:16:59

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Food and Drug Administration
New Drug Application
Biosimilar
Michael R. Taylor

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MoH tightens rules on promotion, marketing of drugs in Oman - Muscat Daily

Added to Collection on: 2025-06-01 17:49:30

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Pharmaceuticals policy
Pharmacy
Pharmaceutical industry
Health care quality
Pharmacovigilance
Medication
Prescription drug
Direct-to-consumer advertising
New Drug Application

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FDA Announces New Domestic Generic Drug Fast-Track Review Program

Added to Collection on: 2025-10-03 22:38:37

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Food and Drug Administration
Pharmaceuticals policy
Pharmaceutical industry
Generic drug
Pfizer
New Drug Application
Center for Drug Evaluation and Research
Ranbaxy Laboratories
Prescription drug prices in the United States

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