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Opinion: The High Cost of Cheaper Drugs
Thirty years ago my infant son was diagnosed with a rare genetic disorder that make even common cold germs potentially life threatening. His disorder -- clinically termed a primary immunodeficiency disease -- started me on my career as a patient activist. Today, my son -- and thousands of others suffering similar diseases...
Opinion: The FDA's Battle With Bogus Drug Claims
(Nov. 23) - We've all sat in front of the TV listening to an earnest-looking man in a white coat confiding in us that the new drug he holds will save – or at least markedly improve – our lives. In the back of our minds, we recalled something about government agencies protecting us from false advertising. When...
drug safety News From AOL
Tafamidis: FDA Shoots Down Drug For Familial Amyloid Polyneuropathy
U.S. drug reviewers on Tuesday recommended rejecting a Pfizer Inc drug because the data did not prove it worked well in treating a rare neurodegenerative disease.
FDA advisers recommend approving weight loss drug
WASHINGTON -Advisers to government health regulators have recommended that that they approve sales of what would be the first new prescription weight-loss drug in the U.S. in more than a decade, despite concerns over cardiac risks.
drug safety News From the Web
- 06/01/12 House passes weak FDA Reform Act Source: Consumers Union The House passed the Food and Drug Administration Reform Act today.
- 05/31/12 FDA User Fee Bills Sail Source: Chemical & Engineering News The legislation "will keep patients safer by modernizing the FDA's inspection process for foreign manufacturing facilities, while also improving access to new and innovative medicines and devices," Sen. Tom Harkin (D-Iowa), chairman of the Senate Health, Education, Labor & Pensions Committee, and Sen. Michael B. Enzi (R-Wyo.), ranking Republican on the committee, say in a joint statement.
- 05/31/12 FDA: Over-the-Counter Teething Medications Can Kill... Source: Brevard Times - Brevard County FL Give the child a teething ring chilled in the refrigerator.
- 05/31/12 NGFA Urges Changes to FDA Guidance on Expanded Access... Source: GrainNet WashingtonâThe National Grain and Feed Association (NGFA) has urged the Food and Drug Administration (FDA) to make several important changes to its draft guidance document that addresses the agency's expanded powers to access facility records under the Food Safety Modernization Act (FSMA).
- 05/31/12 McMorris Rodgers boosts medical device industry in FDA... Source: The Spokesman-Review - Spokane WA American companies that make medical devices would face fewer restrictions and have a better chance of competing against foreign competitors under a section of a bill passed Wednesday by the U.S. House of Representatives.
Background on drug safety
Pharmacovigilance (abbreviated PV or PhV) is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines.
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