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- Investigational New Drug Applications (Inds)-Determining Whether
- Clinical Review Emily R
- Case 1:16-Cv-00903-UNA Document 1 Filed 10/06/16 Page 1 of 11 Pageid #: 1
- Approval Process
- Proposed Formulary Changes Effective 4-1-2019 (Unless Otherwise Noted)
- Prescription Drug Importation
- Investigational New Drug
- Alternative Drug Approval Pathways
- Case 1:14-Cv-01850-KBJ Document 16 Filed 01/12/15 Page 1 of 80
- Clinical Trials of Off-Label Drug Uses: a Regulatory Minefield Medical
- The Ups and Downs of Alkyl‐Carbamates in Epilepsy
- FDA's Proposed Rules to Address Inaccurate Orange
- Caraco V. Novo Nordisk - a Divided Supreme Court −
- FDA's Review Process for New Drug Applications
- Maintaining Marijuana in Schedule I of the Controlled Substances Act
- How FDA Approves Drugs and Regulates Their Safety and Effectiveness
- Off-Label Use of Prescription Drugs
- Generic Drugs Post Novo Nordsik
- FDA Human Medical Product User Fee Programs: in Brief
- [Docket No. DEA-808] Schedules Of
- Regulatory Agency Transparency for Drugs and Biologics: a Comparative Survey of the U.S
- Modernizing Expedited Development Programs FRIENDS of CANCER RESEARCH ANNUAL MEETING 2020
- November 25, 2020/Notices
- Investigational New Drugs: Application, Process, and Trial
- Abbreviations and Acronyms
- Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug Or Biological Products for the Treatment of Cancer
- “The Controlled Substances, Drugs, Device, and Cosmetic Act”
- S:\LORI\CASES\Novo Nordisk V. Caraco\MEMORANDUM -REVISED
- Assessing the FDA Via the Anomaly of Off-Label Drug Prescribing
- Federal Register/Vol. 85, No. 228/Wednesday, November 25, 2020/Notices
- GAO-20-244, FDA DRUG APPROVAL: Application Review Times Largely Reflect Agency Goals
- Realizing the Potential of Focus
- Off-Label Drug Risks: Toward a New FDA Regulatory Approach
- 022255Orig1s000
- In the United States District Court for the District of Delaware
- Fda New Drug Application Process
- Termination of FDA's Unapproved Drugs Initiative Notice
- 213388Orig1s000
- New Drug Applications (Ndas) and Supplements and Amendments to Those Applications to CDER
- 210450Orig1s000
- TAKEDA PHARMACEUTICALS U.S.A., INC., ) ) Plaintiff, ) ) V
- Report 2 of the Council on Science and Public Health (I-18) |
- Oral Solution, 0.6 Mg/5 Ml
- ROCHESTER DRUG CO-OPERATIVE, INC., : Case No
- Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators Guidance for Industry
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
- Practical Applications of Regulatory Requirements for Signal Detection
- Press Release
- FDA Accepts New Drug Application (NDA) to Review Midazolam Nasal Spray, an Investigational Product for the Acute Treatment of Seizure Clusters
- RDLA Policy Primer: Prescription Drug User Fee Act (PDUFA)
- Expedited Programs for Serious Conditions – Drugs and Biologics
- Practical Aspects of Signal Detection in Pharmacovigilance
- Form and Manner for Prescription Drug Price Data Sets, June 11, 2021