DOCSLIB.ORG
Explore
Sign Up
Log In
Upload
Search
Home
» Tags
» Approved drug
Approved drug
FDA Comments on CBD in Foods
Vaccines, Diagnostics, and Treatments): Frequently Asked Questions
Comparisons of Food and Drug Administration and European
New Drugs Are Not Enough‑Drug Repositioning in Oncology: an Update
Drug Development and Clinical Trials 101
Research and Development in the Pharmaceutical Industry
GLOBAL APPROACHES to DRUG DEVELOPMENT: WHEN EX-US CLINICAL DATA CAN SUPPORT US DRUG APPROVALS Understand Factors That Drive Positive US FDA Review
Assessment Report
Clinical Trials Protocol Template
Adaptive Clinical Trial Designs with Surrogates: When Should We Bother?*
Guidance on Conduct of Clinical Trials During COVID-19
Ftc-2018-0055-D-0036-155042.Pdf (8.08
Approval Letter
The Economics of Follow-On Drug Research and Development Trends in Entry Rates and the Timing of Development
FDA and Clinical Drug Trials: a Short History
FDA’S Role in Drug Development
The Adaptive Concept Benefits of Adaptive Trials
CBD RTC Final.Pdf
Top View
Download the Draft Guidance Document
A Matter of Record (301) 890-4188 FOOD and DRUG
Towards Better Delivery of Cannabidiol (CBD)
Drug Repurposing for Triple-Negative Breast Cancer
Alternative Drug Approval Pathways
A Comprehensive Map of FDA-Approved Pharmaceutical Products
How FDA Approves Drugs and Regulates Their Safety and Effectiveness
CREATE BIO Program: a Roadmap from Concept Through Preclinical
Download Author Version (PDF)
22 Case Studies Where Phase 2 and Phase 3 Trials Had Divergent Results
Hormone Therapies: Off-Label Uses and Unapproved Formulations (Resolution 512-A-15) (Reference Committee K)
Referencing Approved Drug Products in ANDA Submissions
Regulatory Agency Transparency for Drugs and Biologics: a Comparative Survey of the U.S
Oncology Medications Policy (1403)
2017 New Drug Therapy Approvals Report
Kintor Pharmaceutical (9939 HK) BUY (Initiation)
Adaptation in Clinical Development Plans and Adaptive Clinical Trial Designs
Preclinical Research in Drug Development
COVID-19 UPDATE- Oregon Board of Pharmacy (OBOP) Information July 17, 2020
Clinical Trials Innovation J U N E 2 0 1 6
Our Citizen's Petition
Opportunities for Combination Drug Development: Data Sources and Innovative Strategies to Assess Contribution of Components
2018 NEW DRUG THERAPY APPROVALS Impact | Innovation | Predictability | Access
Center for Drug Evaluation and Research
Pharmaceutical Policy in the United States in 2019: an Overview of the Landscape and a Venues for Improvement
Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data
NDA 211288 NDA APPROVAL Pfizer Incorporated
International Harmonization of Expedited Programs: Challenges
2020 FDA Drug Approvals Priority Reviews, for Products That Would the FDA Approved 53 Novel Drugs in 2020, the Second Highest Count in Over 20 Years
FDA Drug Approval and Its Relation to a Pharmaceutical Company's Stock
The Biopharmaceutical Pipeline
The Pharmaceutical Industry in 2018. an Analysis of FDA Drug Approvals from the Perspective of Molecules
Spinal Muscular Atrophy Agents TCO 09.2020
STUDY PROTOCOL Amendment 3, 09 September 2020
Using Simulation to Optimize Adaptive Trial Designs: Applications in Learning and Confirmatory Phase Trials
209531Orig1s000
Pharmaceutical Research and Manufacturers of America
A Bayesian Decision Analysis of Clinical Trial Design✩ ∗ ∗ Leah Isakov A, Andrew W