Calling the next six months 'a critical period', the US Food and
Drug Administration's Acting Commissioner Lester Crawford has
unveiled a lengthy list of agency priorities, including continued
work on Good Manufacturing...
A coalition of biopharmaceutical companies and regulatory agencies
has agreed on an electronic data standard that should make it
easier to file product approval dossiers to regulators
electronically, bringing drugs to market more...
The US Food and Drug Administration issued its final report on ways
to combat pharmaceutical counterfeiting and identifies
radiofrequency identification (RFID) as a primary means of tackling
For the past 10 years, drug companies have paid the US Food and
Drug Administration (FDA) fees to review each drug they want
approved, on the grounds that the increased funding for the agency
would accelerate review times and shorten...
The US Food and Drug Administration (FDA) approved 15 New Molecular
Entities in the current year to 30 September, 2003, setting the
stage to outpace last year's registrations by nearly 20 per cent,
says a report from Cutting...
The US Food and Drug Administration has issued its final guidance
document describing its current thinking regarding the scope and
application of 21 CFR Part 11 on electronic records and electronic
signatures; also unveils a series...