Category: FDA Drug Safety Oversight
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AstraZeneca Proposes Early FDA Review For All Prescription Drug Ads
Direct-to-consumer Advertisements Would Be Reviewed Prior To First Use The drug company AstraZeneca Plc has proposed that there be a mandatory FDA review of all direct-to-consumer ("DTC") advertisements for prescription drugs before the ad…
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FDA Announces New Digital Drug Package Inserts / Labels Project
Drug Companies To Submit Digital Versions For All Drugs In Coming Year On November 2, 2005 the FDA announced a new project which will involve drug companies submitting digital versions of drug package inserts,…
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FDA Probably Will Not Require Longer Studies Of New Psychiatric Drugs
Advisory Panel Rejects FDA Proposal: Good Idea, But Wrong Approach In late October 2005 an FDA advisory panel rejected the agency’s recent proposal that would have required the drug companies to do longer-term studies…
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Public Citizen Petitions FDA To Add Black-Box Warning On Impotence Drugs
Erectile Dysfunction Drugs Viagra, Cialis, and Levitra Linked to NAION Vision Loss In mid-October 2005 the consumer-advocacy group Public Citizen petitioned the FDA to add a "black-box" warning to the labels of Pfizer Inc.’s…
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After Two-year Search, FDA Names New Director For Office of Drug Safety
FDA Scientist Gerald Dal Pan Will Be Director of FDA Drug-Safety Office In October 2005 the FDA named staff scientist Gerald Dal Pan its new director of the agency’s Office of Drug Safety. This…
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FDA Wants Longer Studies Done Before Approving New Psychiatric Drugs
Will The FDA Stand Its Ground Against Big Pharma On This Change In Course? Leila Abboud and Anna Wilde Mathews, of The Wall Street Journal ("WSJ"), reported on October 18, 2005 that the FDA…
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FDA To Hold Two-Day Direct-To-Consumer Advertising Meeting In November 2005
Public Meeting to Review Rules Concerning Prescription Drug DTC Advertisements The FDA is considering revising rules about, first, how much side-effect risk information prescription drug commercials must include and, second, whether all direct-to-consumer ("DTC")…
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The Safety of Prescription Drugs During Pregnancy
FDA Uses Five Pregnancy Risk Categories At Present The FDA uses five risk categories to rank the safety of prescription drugs during pregnancy. In recent years, the FDA pregnancy risk categories have gone from…
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“Buyer Beware”, Especially If That New Drug Prescribed To You Was Just Approved By The FDA
FDA Approval Does Not Mean A New Drug Won’t Have Any Serious Side Effects In early October 2005, Jonathan D. Rockoff, of The Baltimore Sun, wrote a good article about an important issue for…
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FDA to Search for Emerging Drug-safety Issues in Health Insurance Company Databases
Public Meeting About Communicating Drug Risks to be Convened in December 2005 In early October 2005 the FDA announced that it has contracted with several large health insurance companies to gain access to their…