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# Alston & Bird Attorneys Review PDUFA 7 Provisions
- URL: https://www.fdaweb.com/alston-bird-attorneys-review-pdufa-7-provisions/
- Published: 2022-06-15T12:00:00.000Z
- Updated: 2026-09-14T17:48:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152072

Four Alston & Bird attorneys say there is bipartisan support in both the House and Senate for the PDUFA 7 reauthorization legislation. Writing in a [Health Care Legislative and Public Policy Advisory](https://www.alston.com/en/insights/publications/2022/06/food-and-drug-amendments-of-2022?ref=fdaweb.com), the attorneys review some of the key provisions of the legislation.

They report that PDUFA 7 places greater oversight emphasis on cell and gene therapies. “Sponsors should be prepared to pay greater attention to the details in their applications, the sufficiency of data being requested to support their products, and the potential for new regulatory requirements to ensure safety,” the advisory says.

PDUFA 7 allows FDA to use a foreign agency’s inspection activity as the basis for pre-approval activities if there is a preexisting agreement with that government. “Manufacturers should preemptively document such agreements in their submissions,” the attorneys write. They also suggest that foreign manufacturers invest in an expert evaluation to assure their facilities meet FDA requirements to prepare for increased agency inspection activities. Lawmakers included mandates and resources for foreign inspections in PDUFA 7, they say.

According to the paper, foreign manufacturers should expect more unannounced FDA inspections through the creation of a pilot program. “They should ensure their facilities adhere to the requirements of quality management and current good manufacturing practice, ensure data integrity, and ensure standard operating procedures are up to date and implemented,” the attorneys write. “FDA will use a risk-based approach to determine what entities warrant an inspection. PDUFA 7 allows compliance history to factor into this decision. Regulated entities should also see greater transparency and clarity from FDA in communication of noted findings and classifications following inspections.”

In PDUFA 7, the attorneys say, FDA is required to develop guidance detailing how it evaluates generic drugs against the innovator drug to help sponsors in the development phase. Also, upon request manufacturers will have access to information related to differences between their drug and a reference-listed drug. Any differences seen in labeling will not prevent approval should FDA approve the changes.