DC battle erupts over off-lable reprints
An FDA plan to allow drug companies to distribute reprints of journal articles dealing with off-label drug uses has run into fire from Sen. Charles Grassley (R-IA), Public Citizen and two university...
View ArticleWoodcock takes GMO to the next level
The FDA's director of drugs, Janet Woodcock, is pushing her manufacturing and product quality experts to "reinvigorate" her brainchild "GMPs (Good Manufacturing Practices) for 21st Century" initiative...
View ArticleFDA's 'Sentinental Initiative' to improve product safety
The FDA says it is undertaking a new initiative to develop a system to query a broad range of databases to identify possible post-marketing adverse events.
View ArticleKweder: new law slows down FDA approvals
While it holds exciting promise for protecting public health, last year's FDA Amendments Act (FDAAA) is actually slowing down new drug approvals, a key agency official warned in June.
View ArticleDrug company outsource probe sought
Sen. Sherrod Brown (D-OH) wants the FDA to evaluate how it protects the American public from drug products containing tainted, outsourced ingredients.
View ArticleAmid high praise, FDA's top cop quits
Calling it "a tremendous loss for the agency," FDA commissioner Andrew von Eschenbach announced in June that the impending departure after three years in the job of the agency's top enforcement officer.
View ArticleCourt limits False Claims Act liability for whistleblowers
In a ruling that provided comfort to drug companies defending dissident former employees' whistleblower suits, the US Supreme Court said in June that False Claims Act liability is limited to acts done...
View ArticleDDMAC responds to queries
DDMAC responses to queries posed by drug sponsors or manufacturers regarding ad/promo issues may only be regarded as official (for legal purposes) if they are received in letter form, the division's...
View ArticleFDA doesn't approve most generics reviewed in first cycle
An HHS Office of Inspector General report says the FDA does not approve 96% of new generic drugs reviewed during their first cycle because they contain chemistry deficiencies.
View ArticleIndustry-sponsored trials reach record high in '07
The number of new industry-sponsored clinical trial starts went up 12% to a record high in 2007, according to data released by Parexel International Corp.
View ArticleDC battle erupts over off-lable reprints
An FDA plan to allow drug companies to distribute reprints of journal articles dealing with off-label drug uses has run into fire from Sen. Charles Grassley (R-IA), Public Citizen and two university...
View ArticleWoodcock takes GMO to the next level
The FDA's director of drugs, Janet Woodcock, is pushing her manufacturing and product quality experts to "reinvigorate" her brainchild "GMPs (Good Manufacturing Practices) for 21st Century" initiative...
View ArticleFDA's 'Sentinental Initiative' to improve product safety
The FDA says it is undertaking a new initiative to develop a system to query a broad range of databases to identify possible post-marketing adverse events.
View ArticleKweder: new law slows down FDA approvals
While it holds exciting promise for protecting public health, last year's FDA Amendments Act (FDAAA) is actually slowing down new drug approvals, a key agency official warned in June.
View ArticleDrug company outsource probe sought
Sen. Sherrod Brown (D-OH) wants the FDA to evaluate how it protects the American public from drug products containing tainted, outsourced ingredients.
View ArticleAmid high praise, FDA's top cop quits
Calling it "a tremendous loss for the agency," FDA commissioner Andrew von Eschenbach announced in June that the impending departure after three years in the job of the agency's top enforcement officer.
View ArticleCourt limits False Claims Act liability for whistleblowers
In a ruling that provided comfort to drug companies defending dissident former employees' whistleblower suits, the US Supreme Court said in June that False Claims Act liability is limited to acts done...
View ArticleDDMAC responds to queries
DDMAC responses to queries posed by drug sponsors or manufacturers regarding ad/promo issues may only be regarded as official (for legal purposes) if they are received in letter form, the division's...
View ArticleFDA doesn't approve most generics reviewed in first cycle
An HHS Office of Inspector General report says the FDA does not approve 96% of new generic drugs reviewed during their first cycle because they contain chemistry deficiencies.
View ArticleIndustry-sponsored trials reach record high in '07
The number of new industry-sponsored clinical trial starts went up 12% to a record high in 2007, according to data released by Parexel International Corp.
View Article
More Pages to Explore .....