FDA Issues New Guidance: Why Your ANDA was Refused?

The FDA has issued two guidance documents intended to assist applicants preparing to submit abbreviated new drug applications (ANDA), clarifying the deficiences that may cause the FDA to refuse-to-receive (RTR) the submissions.

The two guidances included a final guidance on ANDA RTR standards and a draft guidance on ANDA RTR for lack of proper justification of impurity limits.

According to the FDA, between 2009 and 2012, the Office of Generic Drugs refused to receive 497 ANDAs, primarily because the submissions contained serious deficiences.

FDA’s ANDA RTR standards guidance finalizes a draft version of the guidance released in October 2013. In the ANDA RTR impurity limits draft guidance, the FDA describes serious deficiencies in impurity information that could cause FDA to refuse-to-review an ANDA.

According to the draft guidance, typical deficiencies leading to a refuse-to-receive decision include:

(1) failing to provide adequate justification for proposed limits in drug substances and drug products for specified identified impurities that are above qualification thresholds

(2) failing to provide adequate justification for proposed limits for specified identification thresholds

(3) proposing limits for unspecified impurities (e.g., any unknown impurity) that are above identification thresholds. unidentified impurities that are above identification thresholds.

Read the draft guidance here and the final guidance here.

Posted by Tim Sandle