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Headlines Tagged with FDA 8,762 headlines found

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FDA panel recommends dropping serious warning on Pfizer's Chantix

A serious warning on Pfizer Inc's quit smoking drug should be removed, 10 of 19 independent panelists to the U.S. Food and Drug Administration recommended on Wednesday, after reviewing additional trial data on the controversial treatment.
Reuters
added Sep 15, 2016 22:11
16 Views

FDA's New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products

FDA - Food and Drug Administration
added Sep 15, 2016 18:05
6 Views

FDA Advisory Committees Recommend to Remove Boxed Warning in Labeling for Pfizer’s Smoking Cessation Therapy, CHANTIX® (varenicline)

reviewed data from EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study) evaluating the neuropsychiatric safety of CHANTIX® (varenicline). The Committees recommended by a majority vote to remove the boxed warning regarding serious neurops
Business Wire
added Sep 15, 2016 17:52
7 Views

truth initiative ceo calls for fda to ban menthol

truth Initiative® CEO and President Robin Koval called on the U.S. Food and Drug Administration to ban menthol cigarettes at a Tuesday press conference. “It’s a national tragedy when you consider the overwhelming evidence against menthol, combined wit
Truth Initiative (American Legacy Foundation)
added Sep 15, 2016 17:13
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FDA Reviewers Question Chantix/Zyban Safety Study / Inclusion criteria and data collection criticized

"It seems reasonable to conclude that the exact incidence of neuropsychiatric adverse events of significance and perhaps scope of neuropsychiatric adverse events of significance was not accurately captured by the study," FDA reported in a memorandum date
MedPage Today
added Sep 14, 2016 14:12
4 Views

Statement of National Alliance for Hispanic Health on FDA Regulation of Menthol and Flavorings in Tobacco Products English

"The White House can truly celebrate Hispanic Heritage Month this week by directing the FDA to issue a proposed rule to remove all flavored tobacco products, including menthol products, from the marketplace and protect the health of families and children,
PR Newswire
added Sep 14, 2016 13:32
2 Views

New NIST Reference Material Helps Assure Accurate Measurement of Constituents in Tobacco Products

(NIST) has issued a reference material with certified amounts of nicotine and two carcinogens to help ensure accurate testing of commercial tobacco filler—the blended tobacco found in cigarettes. Prepared in collaboration with the Food and Drug Administr
National Institute of Standards and Technology (NIST)
added Sep 16, 2016 15:11
6 Views

BRANNON / GOLDMAN: Up in Smoke / How an FDA drug warning harmed the fight against smoking.

In essence, the fear engendered by warnings of a bizarre but likely non-existent side-effect has led thousands of people to continue smoking, a substantial proportion of whom will assuredly become afflicted with emphysema, lung cancer, heart disease, or
Weekly Standard
added Sep 14, 2016 18:07
2 Views

BRANNON / GOLDMAN: Up in Smoke / How an FDA drug warning harmed the fight against smoking.

In essence, the fear engendered by warnings of a bizarre but likely non-existent side-effect has led thousands of people to continue smoking, a substantial proportion of whom will assuredly become afflicted with emphysema, lung cancer, heart disease, or
Weekly Standard
added Sep 14, 2016 18:07
2 Views

RPT-UPDATE 3-FDA staff flags concerns about Pfizer's quit-smoking drug study (Repeats to additional subscribers)

Pfizer Inc's trial data on Chantix, a drug to help people quit smoking, failed to impress U.S. Food and Drug Administration scientists, in a blow to the company's attempts to have a serious warning removed from the drug's label. The FDA staff, in a prel
Reuters
added Sep 14, 2016 01:51
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