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Category Archives: FDA Updates

20 May

FDA Update: FDA Revises Guidance to Provide Clarification on Actions FDA May Take on an Application When the Agency Cannot Inspect a Facility Due to Factors Including Travel Restrictions

The COVID 19 pandemic continues to change the way business is conducted and procedures are followed.  Even government agencies such as the FDA has had to adapt their systems when travel restrictions have interfered.  Will these alternate methods of conducting inspections cause a permanent shift and will quality assurance/control measures remain up to previous standards?

17 May

FDA Update: FDA Announces Availability of Final Guidance – ICH Q12

On the 11th of May, the FDA announced the release of the final guidance for industry entitled: “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” This was prepared under the support of the International Council for Harmonisation (ICH). ICH Q12, which was originally adopted as an ICH Guideline in November of 2019, establishes

07 May

FDA Update – Discontinued Medical Devices During the COVID-19 Public Health Emergency

The U.S. Food and Drug Administration has updated their discontinued medical devices list during the COVID-19 Public Health Emergency. The recently added items include gastroenterostomy tubes, gastrointestinal tubes, and accessories. Specific items recently added to the discontinuance list are manufactured by Bard Access Systems: 20F PULL Ponsky 20F PUSH Ponsky Bolus Feeding Tube Button Gastrostomy

29 Mar

FDA update: Leveraging Real World Evidence in Regulatory Submissions of Medical Devices

By: Jeff Shuren, M.D., J.D., Director, Center for Devices and Radiological Health (CDRH) and Daniel Caños, Ph.D., M.P.H., Director, Office of Clinical Evidence and Analysis, Office of Product Evaluation and Quality, CDRH Among the many ways that the U.S. Food and Drug Administration protects and promotes the public health is by ensuring the safety and

25 Feb

FDA Update-FDA Issues Policies to Guide COVID-19 Treatment Development

FDA Issues Policies to Guide COVID-19 Treatment Development On February 22, 2021 the FDA released two guidances regarding the development of COVID-19 drugs. The first guidance specifically deals with the development of monoclonal antibody products, while the second guidance is focused on drugs that treat or prevent COVID-19. These guidances contain non-binding recommendations for sponsors

25 Jan

New devices added to the device discontinuance list.

FDA Update New devices added to the device discontinuance list. The FDA is constantly reviewing their emergency use list. As we have been writing and warning that as the amount of needed products come to market via the EUA and 510(k) the FDA will discontinue the items. Companies should be away that they will need

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