de92fb14_egnancy_and_Lactation_Labeling__Suggestions
[0] Industry (8 comments) [Pros] The proposed rule provides clear and complete information to enable informed benefit/risk determinations for pregnant women. The proposed rule is particularly useful for pregnancy. [Cons] There is a high cost with establishing a postapproval registry. By dropping the A, B, C, D, X categories, FDA would discontinue a longstanding and familiar system that provides a quick and simple reference. The use of “low,” “moderate,” and “high” to classify risks can be subjective and confusing. Pregnant women are usually excluded from clinical trials, so obtaining pertinent human data will be quite a challenge. [Suggestions] 
The agency should provide incentive to the industry similar to the “Pediatric Exclusivity Rule.” The proposed rule should not be overly complex or confusing for prescribing physicians and patients.
Pregnancy and Lactation Labeling
Suggestions