CHPA comments on issues associated with the public health benefit of certain drugs being available without a prescription, but only after intervention by a pharmacist.
CHPA appreciates the opportunity to provide comments on FDA’s draft guidance for industry on adverse event reporting for dietary supplements and nonprescription human drug products marketed without an approved application.
CHPA's voluntary plan to address concerns surrounding the safety and efficacy of OTC oral pediatric cough and cold medicines. CHPA, on behalf of its member companies, commits to the following initiatives.
CHPA comments on the proposed rule, which proposes new warning and other labeling requirements for internal analgesic, antipyretic, and antirheumatic OTC drug products.
FDA issued a proposed rule on labeling requirements for OTC human drugs. The announcement proposed a definition for “convenience-size” OTC drug packages as well as the option of alternative labeling requirements for these products. CHPA welcomes the opportunity to comment on the proposed rule changes.
The PCPC and CHPA are pleased to provide these comments in response to FDA's proposed amendment to the final monograph for OTC sunscreen drug products for human use.
This meta-analysis aimed to compare single-dose 10 mg phenylephrine and placebo separately in adult patients with acute nasal congestion due to the common cold.
