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# PhRMA Drug Safety Surveillance Comments
- URL: https://www.fdaweb.com/phrma-drug-safety-surveillance-comments/
- Published: 2020-05-19T12:00:00.000Z
- Updated: 2026-09-14T16:15:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146818

Pharmaceutical Research and Manufacturers of America (PhRMA) says that an FDA draft guidance on best practices in drug and biological product postmarket safety surveillance for FDA staff “is an important step in FDA’s continuous efforts to enhance the efficiency of postmarket drug safety surveillance practices for drugs, biologics, combination products, and medication errors.” The association’s [comment letter](ttps://www.regulations.gov/contentStreamer?documentId=FDA-2019-N-3768-0012&attachmentNumber=1&contentType=pdf) says the draft confirms the risk-based principles by which the agency conducts postmarket surveillance for a wide array of products including drugs, biologics, and combination products. The letter says the draft also discusses how the postmarket surveillance practices are adapted to monitor specific patient populations.

PhRMA includes general and specific recommendations for changes to the draft.