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Checking up on healthcare packaging

Vital issues include validation, FDA regulations, counterfeiting, and the challenges of shipping pharmaceuticals and biologics through the cold chain.(Part I of II)

HEALTHCARE ISSUES. Validation and FDA-related issues continue to have significant impact on manufacturers.
HEALTHCARE ISSUES. Validation and FDA-related issues continue to have significant impact on manufacturers.

Surely one of the most interesting developments to unfold lately in the healthcare product manufacturing arena is the formation of the Coalition for a Stronger FDA (www.fdacoalition.org). The coalition came together officially on Sept. 25 with former government officials, patient group representatives, consumer advocacy organizations, and industry associations bringing it into existence.

“You wouldn't have believed it if you hadn't seen it: A combination of former government officials and diverse interest groups forming a coalition aimed at strengthening the U.S. FDA,” states Eric Greenberg, attorney-at-law and columnist for Packaging World (PW) and Healthcare Packaging (HCP).

“You would have expected consumer and medical patient advocacy groups to be part of this, and they are, but so are some of the major industry trade associations, such as the Consumer Healthcare Products Association,” he continues. That association, it should be pointed out, includes well-known drug manufacturers, the very firms that are regulated by the FDA. So it's a bit ironic that they'd be in a coalition seeking to, in a sense, sharpen FDA's teeth.

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