A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
Devicemakers in Canada must now pay a fee to renew their establishment licenses annually by April 1, or face cancellation and enforcement actions, according to an updated Health Canada guidance. The guidance, which took effect Aug. 10, incorporates a 2010 regulation on establishment licenses that is similar to the FDA’s Medical Device User Fee Act. The GMP Letter