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
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
The two “Rs” — regulatory and reimbursement — are critical elements of the environment in which a medical device product is developed. The design of innovative products in the highly regulated medical environment actually influence all stages of medical device development from the earliest stages of the development effort to its conclusion. Let’s first consider
Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer With more and more companies trying to get into the hand sanitizer manufacturing business, companies need to understand that these products can become contaminated and need to be removed from the market. Here is a notice of voluntary recall expansion of a Non-Alcohol
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
Industry UPDATE: NIOSH Requirements for N95 masks In response to the nation’s effort to control the spread of COVID-19, the NIOSH Respirator Approval Program is accepting and prioritizing applications received for new approvals and extension of approvals submitted by existing approval holders (both domestic and non-domestic manufacturers) and new domestic respirator manufacturers/applicants. NIOSH considers domestic
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
Back in December the FDA released a Federal Register Notice announcing the fees for OTC Drug Manufacturing facilities. Since then, the FDA has withdrawn the FRN. Originally, through the OMUFA webpage, it is stated that “[T]he Department clarifies that persons that were not registered with FDA as drug manufacturers prior to the COVID-19 Public Health
Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into US to Protect U.S. Consumers The FDA has just enacted a countrywide product alert on hand sanitizers being imported from Mexico. Many of these products appear to
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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