Drugs

Comments on Good Review Management Principles Guidance

Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA’s efforts to update its 2005 final guidance on good review management principles and practices (GRMP) for NDAs and BLAs. “Due to the proposed updates and streamlining in the draft guidance,” the association says, “PhRMA strongly urges the agency to update all applicable reference documents … to include the relevant material included in the 4/2005 guidance, but proposed for deletion in the draft guidance. PhRMA believes that it is important for the agency to ensure these reference documents are up-to-date so that review staff have the current tools and references available to them that promote consistency in approaches across therapeutic areas.”

The letter includes PhRMA’s recommendations on (1) ensuring consistency and transparency in communication practices; (2) early postmarketing requirements/postmarketing commitments and labeling discussions as a key component to good review management; and (3) resolving scientific or regulatory issues.

Bayer says FDA should update applicable reference documents, such as CDER’s 21^st Century Review Process Desk Reference Guide, CDER’s Good Review Practices guidance, and CBER’s review processes to include relevant material that was taken out of the GRMP guidance. And it says it’s important that FDA continue to keep the reference documents up-to-date to ensure that review staff have current tools that promote consistency in approaches across therapeutic areas. The company also includes specific line-by-line comments.

Finally, the Biotechnology Innovation Organization (BIO) says the guidance is an important component for informing industry sponsors and FDA staff and reviewers about the agency’s thinking on regulatory review practices and support for a more efficient and transparent review of new therapies. “To both strengthen the document and ensure that all stakeholders have appropriate information and resources related to good review practices,” it says, “BIO requests that FDA cross-reference other tools for sponsors and reviewers in the finalized guidance.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome