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3 Search Results for "fda"
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FDA CDER Databases FDA CDER Databases
- From: pedrooshka
-
Description:
Databases on the CDER Website
- Acronyms and Abbreviations about the database
- Adverse Event Reporting System (AERS) about the database
- Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) about the database
- Bioresearch Monitoring Information System (BMIS) about the database
- Clinical Investigator Inspection List (CLIIL) about the database
- Dissolution Methods Database about the database
- Drug Firm Annual Registration Status about the database
- Drugs@FDA about the database
- FDA Acronyms and Abbreviations about the database
- Inactive Ingredient Search for Approved Drug Products about the database
- National Drug Code Directory about the database
- Oncology Tools about the database
- Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations) about the database
- Postmarketing Study Commitments about the database
- Blog post
- 1 year ago
- Views: 91
- Not yet rated
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The Letter The Letter
- From: viernescasual
-
Description:
FDA Warning Letter
- 1 year ago
- Views: 6
- Not yet rated
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Global Pharmaceutical Regulato Global Pharmaceutical Regulatory Organizations
- From: pedrooshka
-
Description:
Global Organisations (supranational)
- Anatomical Therapeutic Chemical (ATC) classification and Defined Daily Dose (DDD)
- Global Harmonization Task Force (GHTF)
- IFPMA (International Federation of Pharmaceutical Manufacturers Associations)
- IFPMA Clinical Trials Portal
- International Conference on Harmonisation (ICH)
- OECD's Work on Good Laboratory Practice (GLP) and Compliance Monitoring
- The World Intellectual Property Organization (WIPO)
- World Health Organisation (WHO)
Sources of Global Regulatory Information
- CTD Guidelines
- Drug Information Association (DIA)
- reg123.com
- RegSource.com
- RegulatoryWorld (networking for regulatory professionals)
- TOPRA (The Organisation for Professionals in Regulatory Affairs)
USA
US Goverment Bodies
- CBER (FDA) Home Page
- CBER (FDA) What's New
- CDER (FDA) Home Page
- CDER (FDA) What's New
- Code of Federal Regulations (CFR)
- Drugs@FDA
- FDA Guidance Documents
- FDA's Oncology Tools
- Information for FDA-Regulated Industry
- New and Generic Drug Approvals (CDER)
- US Department of Health
- US Government Printing Office
- US Patent and Trademark Office
US Organisations
- American Association of Pharmaceutical Scientists
- Regulatory Affairs Professionals Society (RAPS)
- The Pharmaceutical Research and Manufacturers of America (PhRMA)
Europe
Europe
- European Clinical Trials Directive
- European national agencies
- European organisations
- European regulatory and government bodies
other information
Asia
- China - State Food and Drug Administration
- Hong Kong - Pharmaceutical Service, Department of Health
- India - Central Drugs Standard Control Organization
- India - Ministry of Health & Family Welfare
- Korea Food & Drug Administration
- Malaysia - National Pharmaceutical Control Bureau
- Philippine Council for Health Research and Development
- Philippines - Bureau of Food and Drugs
- Singapore - Health Sciences Authority
- Taiwan - Center fro Drug Evaluation
- Taiwan - Department of Health
- Thailand - Food & Drug Administration
Australia and New Zealand
- Australia's Therapeutic Goods Administration (TGA)
- Australian Department of Health and Ageing
- Australian Drug Evaluation Committee (ADEC)
- Australian drugs designated as orphan drugs
- New Zealand Medicines and Medical Devices Safety Authority
- New Zealand Ministry of Health
- Public Access to ARTG Medicines Information
Canada
- Canadian Society for Pharmaceutical Sciences
- Health Canada - Drug Products
- Health Canada - Medical Devices
- Health Canada - Natural Health Products
- Health Canada Online
- Public Health Agency of Canada
Central and South America
- Argentina - National Administration of Drugs, Food & Medical Technology
- Brazil - Ministry of Health
- Chile - Ministry of Health
- Mexico - Ministry of Health
Middle East
- Israel - Ministry of Health
- Morocco - Ministry of Health
- Turkey - Ministry of Health
- United Arab Emirates
Other sites
Biological and Medical
- British Medical Journal
- British National Formulary
- electronic Medicines Compendium (eMC)
- Hardin MD (Hardin Meta Directory)
- Health, Environment & Work
- healthfinder® (USA)
- Intute: Health and Life Sciences
- Medi-Lexicon
- Medical Abbreviations Search
- Medical Abbreviations Search via reg-info.com
- Medline (PubMed)
- Merck Manual
- Multilingual Glossary of medical terms
- Neuroscience for Kids
- NHS Direct
- NHS National Electronic Library for Health
- The Lancet
- The Pharmaceutical Journal
General Science
- Blog post
- 1 year ago
- Views: 75
- Not yet rated
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