FDA emphasizes a risk-based approach to regulating such medical device software, new legislative mandates and to acknowledge other guidances that have been published since an earlier version of the guidance was issued in 2005. lnkd.in/evZVd_cm

House Republicans agree supply chain challenges are important but don't think PAHPA is the right vehicle for that discussion. lnkd.in/eBwwU63N

The guidance provides the rationale for how FDA assessed how much to charge for various generic drug user fees. lnkd.in/eVZiSF_X

Several law firms are reportedly investigating whether iRhythm Technologies, Inc. violated securities laws by not properly disclosing the matter to investors. lnkd.in/e8G49mrd

The most recent Medical Device User Fee Amendment (MDUFA V) included a number of new performance goals for FDA. Part of those updated performance goals includes new requirements for how it provides feedback through the Pre-Submissi…lnkd.in/e4EYvRsi lnkd.in/eMv_b_AA

Despite a large number of resignations, FDA's Julie Tierney noted its full time equivalent (FTE) headcount has grown from approximately 17,000 in FY 2017 to more than 19,000 today. lnkd.in/eSVZA4mz

AdvaMed, said some of the FDA's guidance language is confusing and isn’t representative of clinical practice. lnkd.in/evMcaDNn

FDA's guidance is meant to ensure the containment systems are reasonably designed to catch the spread of cancerous tissue. lnkd.in/e-_gsddy

Thanks @Zammouka for chatting with me about what I do as a regulatory reporter on the Combinate Podcast. It was a lot of fun. lnkd.in/eHeaxuxB

FDA also argues that the rule will save manufacturers and regulators both time and resources. lnkd.in/eyZfEbb5

Histopathological assessment of tissues samples using whole slide imaging is a major part of nonclinical laboratory studies that can help sponsors and FDA understand the toxicology of a drug. lnkd.in/ev442GA4

FDA said it has received an increasing number of questions from industry about when they can use GASK in their drug and biologics premarket applications, which prompted it to develop the guidance. lnkd.in/eheesYbk

This sounds like a great opportunity for an aspiring government and/or political reporter. Spread the word! lnkd.in/enC93jg5

"That is high priority, and it is our hope that it is out by the end of this year,” said FDA's Jeff Shuren. lnkd.in/e9GwB-mh

The European Medicines Agency's recommendations center around transparency and information sharing between parties such as manufacturers, distributors and regulators. lnkd.in/eCN59bAD

“I think we need IVD specific guidance as much as possible written by knowledgeable IVD people because the speed with which a notified body can complete the technical documentation review if it's high quality is actually quite fast…lnkd.in/eqpqV_6Z lnkd.in/eJ_vtaTN

“The reality of what’s happening is that we will not block the approval of a medicinal product while the companion diagnostic is not yet certified,” said European Medicines Agency's Christelle Bouygues.  lnkd.in/e_xYa4bZ

Robert Califf: “But I also believe that our advisory committee system can be improved to enable our experts to get the best advice possible. Stay tuned for developments in this area.” lnkd.in/emsXbm2v

It helps to make it easy for regulators to find the necessary documentation in sponsor's premarket application, according to experts who spoke at RAPS Euro Convergence 2023 on 12 May. lnkd.in/ejfkHUYE

During a panel discussion at RAPS Euro Convergence on 11 May, experts and regulators reviewed the impact of the Medical Device Coordination Group’s (MDCG) 2022-14 position paper that was issued in August 2022 and is intended to imp…lnkd.in/eDFSuM2q lnkd.in/eDA72PGX