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Plan Carefully In Writing Combo Product Designation Requests, Experts Say

Companies need to carefully consider tactics for ensuring proper regulation of combination products, including looking at whether a manufacturer really needs a formal request for designation, say industry and legal experts.

It is not always the right decision for a company to submit a formal request for FDA to designate a lead product review center designation for a combination product, and when a firm does submit an RFD, a technically accurate product description is crucial, experts said at a recent workshop.

FDA regulates combination products according to their primary mode of action – the single thing a combination product does that’s most important to its therapeutic effects. If that’s unclear, FDA...

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