News

January 19, 2018

CPC Conducts Survey on FDA’s Final Rule on Postmarket Safety Reporting for Combination Products

The Combination Products Coalition (“CPC”) is conducting a brief survey to assess industry readiness for implementation of FDA’s Final Rule on Postmarketing Safety Reporting for Combination Products (available here). We hope to use your responses to help advise FDA on reasonable expectations for how long it will take companies to come into compliance with the Final Rule as well as provide insight about potential hurdles, recognizing that FDA guidance on the Final Rule is still forthcoming.  All of your responses will be kept anonymous.

We would like to have one response per applicable survey (combination product, companion diagnostic, or both) from each company or independent business unit so that information is not duplicated.  Therefore, we ask that you designate an individual at your company/unit to collect information from, and complete a single survey for, the company/unit.  We estimate that it will take approximately 10 minutes to complete the survey.

Take the survey here: https://www.surveymonkey.com/r/MGGXK9D

Please Complete the Survey No Later Than February 2, 2018.

We thank you in advance for your participation. If you have any questions, please feel free to contact Priya Kaulich at PKaulich@ebglaw.com or 312.499.1433.

March 7, 2014

CPC Conducts Surveys on FDA’s Review Process for Combination Products & Companion Diagnostics

The Combination Products Coalition (“CPC”) is conducting anonymous on-line surveys to gather data on manufacturers’ experiences with the review process for combination products and companion diagnostics.  The objective is to help identify areas where there may be problems with, e.g., interCenter or Center-sponsor, communications so that industry and FDA can figure out ways to improve reviews.  We plan to share our results from this survey with FDA and, potentially, with Congress and the broader public to advocate for process improvements. (more…)

May 1, 2013

Op Ed: Counting Our Blessings with the Office of Combination Products

Why the OCP might still be the best thing that has ever happened to industry.

As reported in Seriously, What is Going On at the Office of Combination Products?, some in the medical device community have criticized the Office of Combination Products (OCP) at FDA. In particular, those critics have accused OCP, ironically, both of being weak because the office lacks independent authority and for overstepping its bounds. How is that even possible? (more…)

February 5, 2013

CGMPs for Combination Products–Final Rule and Implementation: An Interactive Analysis with Industry and FDA

In the wake of the U.S. Food and Drug Administration (FDA) issuing the final rule on current Good Manufacturing Practices (CGMPs) for combination products, the Combination Products Coalition (CPC), in collaboration with the Regulatory Affairs Professionals Society (RAPS), will be hosting an interactive session examining the contents of the final rule and the agency’s implementation plan. (more…)

January 23, 2013

Combination Products Coalition pleased with FDA publishings

The Combination Products Coalition is pleased to see the FDA guidance published on when submissions would be required for postapproval modifications to a combination product. Although we will continue to review individually and as a coalition our initial assessment is that it would increase the number of filings pretty radically by declaring that low risk device constituent parts are all of a sudden to be viewed through the PMA lens.

(more…)

January 22, 2013

FDA released the final rule on current good manufacturing practices for combination products

The U.S. Food and Drug Administration (FDA) released the final rule on current good manufacturing practices (cGMPs) for combination products on Friday, January 18, 2013. This rule is intended to clarify how the agency’s GMP requirements should be applied to the manufacturing operations of combination product companies. On the positive side, the rule seeks to streamline the requirements to minimize needless duplication between drug, medical device and biological product requirements. (more…)

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