FDA Issues Draft Recommendations on Submitting Field Alert Reports

The FDA released draft guidance on field alert reports, using a Q&A format to outline the responsibilities of drug applicants for FAR submissions.

The FDA recommends determining if a change or deterioration in a product is significant by evaluating the potential impact on the product’s identity, strength, purity, stability and efficacy, and the possible effect on the consumer.

The investigation should be clearly documented and based on factors specific to the distributed product, including dosage, length of treatment, route of administration, intended use and patient population, the agency said.