Ronald Pace

Ronald Pace

District Director at Food and Drug Administration

Location:
10903 New Hampshire Avenue, Silver Spring, Maryland, United States
HQ Phone:
(301) 796-3900

General Information

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Regional FDA Directors

District Director: Ronald Pace
Telephone: 718-340-7000 E-mail:  ronald.pace@fda.hhs.gov

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FDA warns Pfizer for not reporting side effects

Ronald Pace, director of the FDA's New York office, told Pfizer in the letter dated May 26 that it had not properly documented or investigated reported problems in patients after the drugs were approved for use.
The patient reports "contained serious and unexpected adverse events... that were not submitted until they were identified during the FDA inspection." FDA expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated," Pace wrote. Pace asked Kindler to arrange a meeting between the company and the agency over the violations. Failure to fix the problems could result in legal action without notice and the FDA could delay action in approving the company's pending drugs, among other penalties, Pace said in the letter.

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