PhRMA and BIO seek changes in FDA’s guid­ance to mit­i­gate drug short­ages

Last month, sev­er­al phar­ma ad­vo­ca­cy groups voiced both their ap­proval and con­cerns with the FDA’s draft guid­ance con­cern­ing how to han­dle po­ten­tial drug short­ages. The draft was in­tend­ed to help com­pa­nies form and com­mit to risk man­age­ment plans (RMPs) to as­sist with any short­ages of drugs or bi­o­log­ics prod­ucts.

While groups such as Civi­ca and The Biosim­i­lars Fo­rum of­fered com­ments to the FDA to change the guid­ance, oth­er groups are let­ting the FDA know its con­cerns.

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