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 FDA's task force on counterfeiting of drugs issued its
preliminary report on schedule at the end of last week, and said
that it would be preparing a final document for early in 2004.
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...
The pharmaceutical industry is facing the possibility of earlier
generic competition for its branded products from 18 August, when
new legislation in the USA comes into effect.
Roche's Burgdorf plant making insulin pumps has serious regulatory
compliance problems, said the FDA, which could block import of the
products unless resolved.
Crestor (rosuvastatin), the 'superstatin' developed by AstraZeneca,
has been recommended for approval by a US Food and Drug
Administration advisory panel.
