FDA develops pilot to harmonize international gene therapy regulations

The FDA is set­ting out to stream­line in­ter­na­tion­al reg­u­la­tions of gene ther­a­pies with a pi­lot pro­gram to re­view ap­pli­ca­tions along­side glob­al reg­u­la­to­ry part­ners, an agency spokesper­son told End­points News.

The spokesper­son said that the pro­gram, called the Col­lab­o­ra­tion on Gene Ther­a­pies Glob­al Pi­lot, is part of the agency’s work to­ward glob­al reg­u­la­to­ry har­mo­niza­tion of these prod­ucts. The FDA is work­ing with in­ter­na­tion­al part­ners, glob­al reg­u­la­tors and the World Health Or­ga­ni­za­tion on these ef­forts, they said.

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