FDA has new guidelines for informal review processes for medical device applications. A new guidance is aimed at accelerating review times and suggests when and how applicants should contact the agency during a review cycle.
Since more resolute performance goals have been set forth by the agency after the 2007 FDA Amendment Act, increased interaction during the review process between the FDA and life science industries has become an issue of note. According to the guidance, interactive reviews will facilitate increased informal interaction between the FDA and applicants and enable the exchange of vital scientific and regulatory information. To view the guidance, follow the link below.
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