Regulatory Focus Articles
FDA, DHS Alert to Cybersecurity Flaws Affecting Medtronic Cardiac Devices, Programmers, Monitors
Fri, 22 Mar 2019 19:29:00 GMT
Hundreds of thousands of units of Medtronic implantable cardiac devices, programmers and home monitors are vulnerable to cybersecurity incidents, according to two US federal government notices.
Natural History Studies for Rare Diseases: FDA Drafts Guidance
Fri, 22 Mar 2019 16:52:07 GMT
The US Food and Drug Administration (FDA) on Friday published new draft guidance to help inform the design and implementation of natural history studies that can be used to support the development of treatments for rare diseases.
 
Recon: Democrats Push Back Against 10-Year Biologic Exclusivity in Nafta Rewrite; Snapchat Looks to Woo Pharma Advertisers
Fri, 22 Mar 2019 16:48:38 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
EU MDR/IVDR Coordination Group Urges Exemption Clarification
Fri, 22 Mar 2019 16:25:52 GMT
The European Commission (EC) issued a new document Friday in which the group established by the EU’s new medical device regulations argued that clarification of Article 54(2)b is “extremely urgent.”
 
EMA on Brexit: Risk for Drug Shortages Decreases
Fri, 22 Mar 2019 15:04:08 GMT
As the UK and EU agreed to extend the Brexit deadline, the European Medicines Agency’s (EMA) Management Board said following its first meeting in Amsterdam that the prospect for centrally authorized products to be at risk of shortage “continues to decrease.”
 
Public Citizen, FDA Advisor Call for Moratorium on Opioid Approvals
Thu, 21 Mar 2019 20:25:32 GMT
Nonprofit advocacy group Public Citizen on Thursday filed a citizen petition calling for the US Food and Drug Administration (FDA) to impose a moratorium on approving new or reformulated opioids until the agency implements recommendations from a 2017 report by the National Academies of Science, Engineering and Medicine.
Reorganization of FDA’s Office of the Commissioner to Begin Soon
Thu, 21 Mar 2019 20:13:29 GMT
Beginning 31 March, the US Food and Drug Administration’s (FDA) Office of the Commissioner will reorganize and make several changes to various offices within FDA, including the Office of New Drugs (OND).
 
FDA’s OCP Works to Modernize Review Functions
Thu, 21 Mar 2019 20:06:10 GMT
Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP) in 2018 and will be used to prepare for 2019 priority areas related to the opioid crisis, antimicrobial resistance and rare diseases.
 
EU Regulatory Roundup: Denmark Teams With WHO to Help Build Regulatory Capacity in Poorer Countries
Thu, 21 Mar 2019 16:46:31 GMT
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
 
Recon: Biogen, Eisai Scrap Two Late-Stage Alzheimer’s Studies
Thu, 21 Mar 2019 16:28:58 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
To Prevent Losartan Shortages, FDA Allows Higher Impurity Levels
Thu, 21 Mar 2019 16:25:50 GMT
To ensure patient access to the blood pressure medicine losartan, the US Food and Drug Administration (FDA) said late Wednesday that it will not object to certain manufacturers temporarily distributing losartan with one impurity above the interim acceptable intake limit until that impurity can be eliminated.
 
UK Offers More No-Deal Brexit Guidance on Clinical Trials, PIPs
Wed, 20 Mar 2019 18:50:34 GMT
With a glimmer of hope for a short extension to the Brexit deadline of 29 March, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is still releasing guidance in case Brexit occurs without a deal in place.
EMA Follows FDA Warning on Xeljanz Blood Clot Risks
Wed, 20 Mar 2019 18:40:34 GMT
The European Medicines Agency (EMA) on Wednesday warned patients and healthcare professionals against exceeding the recommended dose of Pfizer’s rheumatoid arthritis (RA) drug Xeljanz (tofacitinib) due to an increased risk of blood clots forming in the lungs.
Breast Implant Manufacturers Draw FDA Warning Letters Over Post-Approval Studies
Wed, 20 Mar 2019 18:37:08 GMT
The US Food and Drug Administration (FDA) sent warning letters this week to two breast implant manufacturers over their failures to comply with FDA’s post-approval study (PAS) requirements.
 
OMB Reviews Proposal to Add Prices to Pharma TV Ads
Wed, 20 Mar 2019 17:34:05 GMT
The Office of Management and Budget (OMB) this week began reviewing a proposed rule that would require drug companies to include list prices in direct-to-consumer television advertisements.
 
Recon: Pfizer Buys Stake in French Gene Therapy Developer Vivet
Wed, 20 Mar 2019 16:44:09 GMT
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
IMDRF Explains How to Build Submissions Using its Table of Contents Structure
Wed, 20 Mar 2019 16:40:58 GMT
The International Medical Device Regulators Forum (IMDRF) issued a final assembly and technical guide on building submissions using the IMDRF Table of Contents (ToC) structure, including harmonized technical guidelines on the acceptable folder structure and file format(s) for ToC-based submissions.
 
EU Publishes First Corrigenda for MDR, IVDR
Wed, 20 Mar 2019 16:11:43 GMT
As part of an effort to fix the mistakes, inconsistencies and slightly correct the EU’s Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR), the Council of the European Union this week released two corrigenda.
 
WHO Panel Calls for Global Gene Editing Registry
Tue, 19 Mar 2019 19:22:28 GMT
The World Health Organization’s (WHO) newly-formed advisory panel on human genome editing is calling for the creation of a central registry for all human genome editing studies following a two-day meeting that concluded in Geneva on Tuesday.
Biosimilar Groups Offer Proposals to Help US Better Mirror EU Successes
Tue, 19 Mar 2019 19:02:08 GMT
With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups from the US and EU on Tuesday called for several structural changes so that the US can see the same competitive environment that Europe currently enjoys.
 

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