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Pharmaceuticals
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How to Report Adverse Reactions and Other Problems with Products Regulated by the Food and Drug AdministrationBy U.S. Dept. of Health and Human Services, Office of the General CounselPublication from the Food and Drug Administration (FDA) on how to report complaints and adverse reactions with products regulated by the FDA.
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News & Analysis
Latest News
Research Tools
Associations
- American Association of Pharmaceutical Scientists Features pharmaceutical news, reports, and scientific journals.
- Association of Food and Drug Officials Organization concerned with the development and enforcement of uniform food, drug and consumer product safety laws and regulations.
- Canadian Drug Manufacturers Association Represents the Canadian-based pharmaceutical industry. Covers industry facts and issues, market trends, and generic drug information.
- Food and Drug Law Institute Dedicated to improving the understanding of the laws, regulations and policies affecting healthcare technologies, food and cosmetics.
- Japan Pharmaceutical Association Includes information on the Japanese medical insurance system, drug supply and distribution, and the Code of Ethics for Pharmacists.
- Japan Pharmaceutical Manufacturers Association Voluntary organization of research-based pharmaceutical manufacturers. Includes publications, industry information, regulations, and Japanese Pharmaceutical Reference database.
- Nonprescription Drug Manufacturers Association of Canada National association representing manufacturers, marketeres and distributors of self-care products. Includes policy/position papers, self-medication digest, and industry information.
- Parenteral Drug Association (PDA) International association for pharmaceutical science and technology. Includes science and regulatory information.
- Pharmaceutical Research and Manufacturers of America (PhRMA) Represents the country's leading research-based pharmaceutical and biotechnology companies. Features policy views, industry profile and primer, news, and press releases.
- The Food and Drug Law Institute An impartial forum for the FDA, other government agencies, and the legal, business, academic and consumer communities.
Government Resources
- Adverse Drug Reaction System Database of adverse drug reactions primarily reported by health professionals.
- Consumer Drug Information Medications recently approved by the FDA.
- FDA Enforcement Report Index Recalls & field corrections, medical device alerts, injunctions, seizures, indictments and other FDA regulatory activity.
- Food and Drug Administration Regulates drugs, medical devices, biologics and more.
- U.S. Patent & Trademark Office Information regarding patents and trademarks, including links to forms, fee information, news, legal materials, statistics, and related Web sites.
Laws
- Federal Food, Drug and Cosmetic Act From the Food and Drug Administration.
- Food and Drugs Codes U.S. Code, Title 21.
- Food and Drugs Regulations Code of Federal Regulations (CFR), Title 21.
- Patents Codes U.S. Code, Title 35
- Patents, Trademarks and Copyrights Regulations Code of Federal Regulations (CFR), Title 37
Web Sites
- Drug Topics Online news magazine for pharmacists.
- RegSource.com - Generics/OTC Regulatory information on drugs, biologics, devices and pharmaceuticals.
- Statisticians in the Pharmaceutical Industry Forum for discussion of statistics in the pharmaceutical industry.
Westlaw Databases
- Andrews Pharmaceutical Litigation Reporter (ANPHARLR)
- FDA Enforcement Report (DJN/R) (FDAER)
- FDA Enforcement Report (FHTH-FDA)
- Federal Cases (FHTH-CS)
- State Law Cases (MHTH-CS)
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