Regulatory News

News for regulatory professionals, covering the latest from regulators, new and proposed legislation, research and studies, regulatory trends affecting the healthcare product industries, international standards and more.

When is a REMS Necessary: FDA Explains in Draft Guidance

The draft guidance from the US Food and Drug Administration (FDA), unveiled earlier this month, tries to further explain the application of its risk evaluation and mitigation strategy (REMS) regulatory paradigm, which can delay generic drug competition.

Categories: Drugs, Government affairs, Labeling, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: REMS, generic drugs, FDA and REMS
WHO to Add $20m in Industry Fees to Keep Prequalification Program Sustainable

The World Health Organization (WHO), industry groups and other partners on Friday announced a new financing arrangement that will add $20 million annually in new industry fees to ensure the financial sustainability and quality of WHO’s prequalification program.

Categories: Active pharmaceutical ingredients, Biologics and biotechnology, Drugs, Government affairs, Quality, Reimbursement, Regulatory strategy, Regulatory intelligence, Submission and registration, News, Europe, Asia, Latin America and Caribbean, Africa, Middle East, WHO Tags: WHO, prequalification of vaccines, prequalification of medicines, WHO funds
Regulatory Recon: Cures Bill a Top Priority for Lame-Duck Period; Two Died in Boehringer Trial (30 September 2016)

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, News, US, Europe, Asia, FDA, EMA, CFDA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Former Regulatory Affairs Director Charged With Insider Trading

The US Securities and Exchange Commission (SEC) on Thursday charged Robert Gadimian, former senior director of regulatory affairs for Puma Biotechnology, with making more than $1.1 million thanks to non-public information linked to the company’s breast cancer treatment.

Categories: Drugs, Clinical, Crisis management, Ethics, News, US, FDA Tags: regulatory affairs, insider trading, Puma Biotechnology
GAO: FDA Needs to Improve Cybersecurity Measures With Non-Public Info

Despite recent steps to improve cybersecurity, the US Government Accountability Office (GAO) said Thursday that the US Food and Drug Administration (FDA) needs to better protect industry and public health data.

Categories: Postmarket surveillance, Project management, News, US, FDA, Business and Leadership Tags: IT security, non-public data and FDA
Priority Review Voucher Fees to Decline in FY 2017

The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US, FDA Tags: priority review vouchers, PRV, rare pediatric disease voucher, golden ticket, tropical disease priority review voucher
European Regulatory Roundup: AstraZeneca Pulls Cancer Drug After Disagreement With EMA (29 September 2016)

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: Biologics and biotechnology, Drugs, Crisis management, Ethics, News, Europe, EMA, EC, MHRA, NICE Tags: AstraZeneca, Alexion, Strensiq, PCWP
EMA Contests Two Judicial Decisions Over Clinical Trial Transparency Efforts

The European Medicines Agency (EMA) on Thursday announced it has appealed two interim orders by the President of the General Court of the EU, which suspended the release of clinical study documents requested by third parties under a new transparency regulation.

Categories: Clinical, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC Tags: DMD drugs, PTC Therapeutics, clinical trial transparency, President of the General Court of the EU
Regulatory Recon: Novo Nordisk to Cut 1,000 Jobs; Congress Passes $1.1B in Zika Virus Funds (29 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, NICE, CDSCO Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA and the Public Interest: The Problem With Drug Reviewers Moving to Industry

A new analysis published in The BMJ finds that more than a quarter of hematology and oncology drug reviewers at the US Food and Drug Administration (FDA) left the agency to work or consult for the biopharmaceutical industry between 2001 and 2010.

Categories: Biologics and biotechnology, Drugs, Ethics, Government affairs, News, US, Europe, FDA, EMA Tags: Conflict of Interest
FDA Approves First Automated Insulin Delivery Device

The US Food and Drug Administration (FDA) on Wednesday approved Medtronic’s artificial pancreas, known as the MiniMed 670G hybrid closed looped system, which is the first device approved in the US to automatically monitor glucose and provide appropriate basal insulin doses in people 14 and older with type 1 diabetes.

Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH Tags: artificial pancreas, Medtronic, automated insulin
Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program

The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December.

Categories: Drugs, Compliance, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: rare pediatric priority review voucher, PRV program, PRV extension, Bob Casey
Regulatory Recon: CFDA Review Finds 80% of Chinese Clinical Trial Data is Fabricated; Teva Alleges Fraud in $2bn Acquisition (28 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Senator Seeks More From Mylan on Intent to Repress Teva’s EpiPen Generic

Sen. Patty Murray (D-WA) on Tuesday sent a letter to Mylan CEO Heather Bresch seeking more details, including e-mail communications, on the ways that Mylan attempted to keep Teva’s generic EpiPen from coming to market.

Categories: Drugs, Medical Devices, Crisis management, Government affairs, Regulatory strategy, News, US, FDA Tags: Mylan, Teva, EpiPen, Patty Murray, citizen petition, pay-for-delay settlement
'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers

The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, News, US, China, FDA, APIs Tags: Data integrity, warning letter
Industry Weighs in on FDA Draft Guidance on Infectious Disease NGS-Based Diagnostics

Diagnostic companies Illumina, Roche, AstraZeneca and others are offering a peek inside how they view next-generation sequencing (NGS) diagnostic devices, with the release of 20 comments on recent US Food and Drug Administration (FDA) draft guidance.

Categories: In vitro diagnostics, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Illumina, Roche, AstraZeneca, next-gen sequencing, infectious disease diagnostics
Regulatory Recon: Kite Looks to File CAR-T Application; FDA Approves J&J's Stelara for Crohn's (27 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
AdvaMed and Pfizer Offer Concerns on FDA’s Benefit-Risk Draft Guidance for Devices

Concerned with a lack of specifics, Pfizer and US medical device industry group AdvaMed are calling on the US Food and Drug Administration (FDA) to amend its draft guidance on factors to consider regarding the benefits and risks for compliance and enforcement actions.

Categories: Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Pfizer, AdvaMed, benefit-risk guidance for medical devices, FDA draft guidance
Asia Regulatory Roundup: CFDA Continues Crackdown on Dishonest Drug Manufacturers (27 September 2016)

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: Drugs, Medical Devices, News, Asia, MHLW, CFDA, CDSCO Tags: Asia Regulatory Roundup, DCGI, China medical devices, CFDA enforcement
EMA and FDA Set Up New Working Group on Rare Diseases

The new collaboration between the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) announced Monday will improve the sharing of information on various aspects of the development and scientific evaluation of medicines for rare diseases.

Categories: Drugs, Government affairs, News, US, Europe, FDA, EMA Tags: rare disease, FDA and EMA collaboration, rare disease cluster
Biomarkers Used as Outcomes: FDA Wants to Hear More on Examples

The US Food and Drug Administration (FDA) is seeking comment from interested stakeholders to determine the utility of a list of examples of biomarkers used as outcomes in the development of FDA-approved new molecular entities and new biologics.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US, FDA Tags: biomarkers, biomarker examples, clinical trial biomarkers, FDA and biomarkers
GDUFA II: FDA Looks to Speed Up Generic Drug Approval Process

On 21 October, the US Food and Drug Administration (FDA) will meet to discuss plans for the second iteration of the Generic Drug User Fee Act (GDUFA II) under which FDA says it will begin offering eight-month and 10-month reviews of abbreviated new drug applications (ANDAs) between 2018 and 2022.

Categories: Generic drugs, Compliance, Government affairs, Manufacturing, News, US, FDA Tags: ANDA backlog, generic drug reviews, generic competition
CDSCO Advances Draft Medical Device Rules, Outlines Fees

India's Central Drugs Standard Control Organization (CDSCO) on Monday released an updated version of its draft rules for medical devices, including fees payable by industry, after consultations with stakeholders.

Categories: Medical Devices, News, India, CDSCO Tags: Fees, Draft Medical Device Rules 2016
Regulatory Recon: Pfizer Decides Not to Split; Regeneron Gets Priority Review for Eczema Drug (26 September 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
ISO 13485: Ex-FDA Official Kim Trautman Gives Advice on Transitioning

Speaking at RAPS' 2016 Regulatory Convergence, leading medical device quality systems expert and former FDA official, Kim Trautman, urged attendees to begin their transition to the recently released ISO 13485:2016 as soon as possible.

Categories: Medical Devices, News, FDA, ISO Tags: ISO 13485:2016
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