Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA access to public health databases imperative, report says

This article was originally published in The Silver Sheet

Executive Summary

FDA must tap into various public health databases to identify adverse events and product risks, according to a Nov. 29 report from the Subcommittee on Science and Technology, an ad hoc panel of the FDA Science Board. "Similarly, by leveraging standards and access to growing health information exchanges, the FDA should catalyze and participate in the development of efficient premarket and postmarket data exchange networks required to ensure the quality, safety and efficacy of medical and consumer products," the report notes. The report also charges that the agency's information technology (IT) infrastructure is inadequate and prevents FDA from fulfilling its regulatory mandates. Further, the subcommittee recommended that FDA adopt advanced data mining and analytical methodologies to beef up its adverse event and signal detection, as well as develop risk-based models for selecting which manufacturers to inspect. "The IT situation at FDA is problematic at best - and at worst it is dangerous," the report states. "Reports of product dangers are not rapidly compared and analyzed, [and] inspectors' reports are still handwritten and slow to work their way through the compliance system.

You may also be interested in...



EWG Study Suggests More Than One In 10 Talc-Based Cosmetics Contain Asbestos

The Environmental Working Group and Scientific Analytical Institute say inadequate testing of talc-containing personal-care products is to blame for findings of asbestos in cosmetics, including three of 21 powder-based cosmetics SAI analyzed at EWG’s request. They continue to push for updated testing standards that include electron microscopy as a core component.

Atlas Biomed Unlocking Japan’s OTC Market With Direct-To-Consumer DNA And Microbiome Tests

Can Atlas Biomed unlock Japan's self-care market with its direct-to-consumer DNA and microbiome tests? HBW Insight catches up with the company's co-founder and CEO to discuss this and also how Atlas has been driving its European expansion plans despite coronavirus. 

Hair Supplement Linked To Cases Of Severe Hepatitis In France

France's ANSES warns women using oral contraceptives not to use a supplement marketed by UK firm Hairburst after linking the product's consumption to two cases of severe acute hepatitis.

Topics

UsernamePublicRestriction

Register

LL1121650

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel