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December 14, 2021  •  Whitepaper

Meeting Report: Vaccine Stability Considerations to Enable Rapid Development and Deployment

The Stability Community of the American Association of Pharmaceutical Scientists (AAPS) held a virtual workshop on "Vaccine Stability Considerations to Enable Rapid Development and Deployment", on March 24-25, 2021. The workshop included distinguished speakers and panelists from across the industry,…

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January 22, 2021  •  Whitepaper

Overview of FDA Timelines Associated with Traditional 510(k)s

The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking applications…

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October 19, 2020  •  Whitepaper

Breakthrough Designation: Is it the path for your device?

Overview You are working on creating a novel new device. It is an exciting time! But with novelty comes many unanswered questions, including what is the best regulatory pathway. The Breakthrough Device Program may be a part of that pathway. In this paper, consultants Christy Foreman, MBE and Becky Ditty…

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September 27, 2018  •  Whitepaper

Understanding the CDRH Reorganization and Its Potential Impact on Premarket Submission Reviews: Frequently Asked Questions & What You Need to Know

Overview It can be hard to keep up with the rapid pace of changes in FDA's regulations and review policies for medical devices. One area that changes roughly every 5 years in some capacity is the organizational structure of the Center for Devices and Radiological Health (CDRH). However, the new reorganization…

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December 15, 2017  •  Whitepaper

Regulatory Strategy for Pre-IND Meetings with FDA: Why Meet & What to Ask

Overview For those developing a new biologic or pharmaceutical product, Pre-Investigational New Drug Application (pre-IND, PIND) meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors…

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November 14, 2017  •  Whitepaper

Medical Device De Novo Classification Applications: Frequently Asked Questions and What You Need to Know.

Overview In recent years, the FDA has overhauled the De Novo program to make it simpler and more attractive to medical device manufacturers. This increased emphasis has resulted in an accelerated rate of change in the Agency's regulations, processes and procedures, including the recent guidance document…

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October 24, 2016  •  Whitepaper

Data Integrity and the Pre-Approval Inspection: An Inspector’s Experience

Overview Data integrity has always played an essential role in regulatory application review and cGMP inspections – a trend that will only continue to grow in the coming years. The FDA's April 2016 draft guidance document "Data Integrity and Compliance with cGMP" is an important step by the Agency…

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April 25, 2016  •  Whitepaper

Zika Virus: The Development of Medical Countermeasures

Overview The global concern about Zika virus continues to grow as the international community braces for its continued spread. There is currently no vaccine for the virus. However, the increasing evidence of vertical transmission, teratogenic effects and potentially severe complications such as GBS has…

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