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Guidance

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Q&A Guidance Doc Dives Into Combination Product User Fees

The document explains how user fees for combination products are assessed and administered, as well as waiver possibilities.

Regulation User Fees

FDA Drops Final Guidance On Devices Designed To Treat Opioid Abuse

The FDA has published final guidance to assist developers of medical devices designed to treat opioid use disorder, along with considerations for sponsors of clinical studies to evaluate those devices.

FDA Guidance Documents

FDA Addresses Medical Product Misinformation For The Post-COVID World

The FDA’s updated guidance on internet responses to misinformation adds considerations for a post-COVID, social media influencer world. 

Guidance Documents Safety

Global Medtech Guidance Tracker: June 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Guidance Documents Regulation

FDA Offers Draft Guidance For Developers Of Drug Delivery Devices

The US FDA has published draft guidance for developers of drug delivery devices listing recommendations related to device design outputs essential for establishing and assessing the performance of their products.

FDA Combination Products

Diversity Action Plans Should Be Brief And Waiver Requests Filed Early, US FDA Says

In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.

Diversity & Inclusion Clinical Trials

Experts Say LDT Small-Business Compliance Guide Does Little To Persuade

A new FDA lab-developed test compliance guide for small enterprises summarizes agency policy but fails to address clinical lab industry concerns about the LDT final rule.

Regulation FDA

Diversity Enrichment: US FDA Guidance Suggests Sponsors May Need To Overenroll Key Groups

New draft guidance on clinical trial diversity action plans pushes for disproportionately high enrollment of traditionally underrepresented groups, while also asking companies to tailor global programs to US populations and consider diversity aspects that Congress did not outline. 

Diversity & Inclusion Clinical Trials

FDA Finalizes Definitions Of Delaying Or Denying Inspections

The US FDA has issued its final guidance defining manufacturer behaviors it deems as hampering the agency’s ability to conduct an inspection. In a previous draft guidance, the agency expanded its longstanding policy on inspections of drug companies to include device makers as well.

FDA Guidance Documents

Global Medtech Guidance Tracker: May 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Sixty-five documents have been posted on the tracker since its last update.

International Guidance Documents

Expert: FDA Missed Opportunity For Software In Remanufacturing Guidance

Device attorney Jason Brooke says that the FDA’s recent guidance document on device remanufacturing represents a “missed opportunity” to discuss software.

Guidance Documents Regulation

Q-Sub Guidance Needs Clarity On Informal Meetings And Timelines, Say Commenters

Stakeholders say the US FDA’s Q-sub guidance could use some tweaking, especially for identifying when informal meetings with the agency are more appropriate than formal ones and creating less burdensome timelines.

FDA Guidance Documents

France Consults On Best Practice Guidelines For Decentralized Trials

The CNIL plans to update its data protection methodologies based mostly on the results of a new consultation and the outcome of a pilot in which companies are asked to identify the challenges they have faced when designing trials with decentralized elements.

Clinical Trials Guidance Documents

EMA Answers More Questions For Manufacturers of Drug-Device Combos

Will it be necessary to provide a new medical device notified body opinion when changes are being made to the medicine in an integral drug-device combination product? This is just one of the new topics addressed in an updated Q&A document from the European Medicines Agency.

Europe Approvals

Remanufacturing Guidance Adds Info On Premarket Requirements For Remanufacturers

After clarifying what a remanufactured device is in its 2021 draft guidance, FDA’s final guidance adds information about regulatory requirements for companies whose devices qualify as remanufactured.

Guidance Documents FDA

Global Medtech Guidance Tracker: April 2024

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-five documents have been posted on the tracker since its last update.

Guidance Documents Regulation
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