New FDA draft guidance for dispute resolution

A new FDA draft guidance for dispute resolution allows the manufacturing site to challenge FDA inspection findings on the Form 483 10 days after the Form 483 was issued. The district office or applicable ORA office should respond in writing within 30 days. An unfavorable decision can be appealed within 60 days of the decision to a review committee with representatives of all three centers.

To read more go to: http://www.fda.gov/cder/guidance/5804dft.pdf