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.

EMA Offers New EudraVigilance Checklist for Sponsors, MAHs

The European Medicines Agency (EMA) on Monday published a checklist to help marketing authorization holders (MAHs) and sponsors prepare for the technical changes ahead of the launch of the new EudraVigilance adverse event system on 22 November 2017.

Categories: Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, Europe, EMA Tags: EudraVigilance, marketing authorisation holders, individual case safety reports
Senators Ask FDA Commissioner What Help He Needs to Tackle REMS Abuse

In a letter sent to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb last week, a bipartisan group of senators say they want to know what FDA can and cannot do to address certain tactics used to delay generic drug competition.

Categories: Generic drugs, Submission and registration, News, US, FDA Tags: REMS, Generic Competition
FDA: Interchangeable Biosimilar Approvals Expected Within 2 Years

The launch of the US biosimilars market has been slow since the pathway for approvals was set up in 2010, with only five US Food and Drug Administration (FDA) biosimilar approvals, none of which have been approved as interchangeable biosimilars.

Categories: Biologics and biotechnology, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: biosimilars, interchangeable biosimilars, interchangeability, biosimilar substitution
FDA, NCI to Collaborate Further on Cancer Research

The US Food and Drug Administration (FDA) and National Cancer Institute (NCI) on Monday unveiled a memorandum of understanding (MOU) to further cooperate on understanding the molecular biology of cancer as it relates to diagnostic measurements, product development and treatment.

Categories: Combination products, Drugs, In vitro diagnostics, Medical Devices, Government affairs, News, US, CDRH Tags: National Cancer Institute, proteogenomics, cancer research
Novel Trial Endpoints Generated by Mobile Tech: CTTI Offers Recommendations

The Clinical Trials Transformation Initiative (CTTI), a public-private partnership established by Duke University and the US Food and Drug Administration (FDA), on Monday released new recommendations on developing novel clinical trial endpoints generated by mobile technology.

Categories: Drugs, Medical Devices, Clinical, News, US, FDA Tags: CTTI, mobile technology and clinical trials, novel trial endpoints
Regulatory Recon: Gottlieb Prioritizes Release of CRLs; FDA Approves Portola's Blood Clot Prevention Drug (26 June 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Decision on EMA Relocation Set for November, Council Agrees on Bidding Procedure

At the EU Summit in Brussels on Thursday, the European Council backed a procedure to determine where the European Medicines Agency (EMA) will be relocated to following the UK's withdrawal from the EU.

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Europe, EMA Tags: Brexit, EMA Relocation
EMA Recommends New HCV, Cancer and MS Drugs for Approval

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended eight new medicines for approval, including two pan-genotypic hepatitis C (HCV) drugs and a third biosimilar for AbbVie's Humira (adalimumab).

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, Europe, EMA Tags: CHMP, Maviret, Vosevi, Imraldi
Regulatory Recon: FDA Rejects Pfizer Epogen Biosimilar Over Warned Manufacturing Site; Novartis, CSL Behring & Roche Pick Up US Approvals (23 June 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Senate Health Bill Would Repeal Device Tax

Senate Republicans on Thursday released a draft version of their bill to repeal the Affordable Care Act that, like the American Health Care Act passed in the House last May, would repeal most of the taxes created by the 2010 law.

Categories: Medical Devices, Government affairs, News Tags: Medical Device Tax
European Regulatory Roundup: EMA Tasks Working Groups With Redistributing Workloads in Run Up to Brexit (22 June 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance, News, Europe, EMA, MHRA Tags: European Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Novartis Drug Cuts Heart Attack, Stroke Risk in Phase III Trial; Kamada Withdraws EU Application for ALPHA-1 Antitrypsin Drug (22 June 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Warns Chinese API Maker for Data Integrity Issues

The US Food and Drug Administration (FDA) on Monday released a warning letter sent to active pharmaceutical ingredient (API) maker Qinhuangdao Zizhu Pharmaceutical for data integrity issues uncovered during an inspection of its Hebei province facility late last year.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Manufacturing, News, US, China, FDA Tags: Data Integrity
Regulating CRISPR: FDA and Industry Offer Perspective

Although the US market is likely more than a year or two away from seeing any commercialized medical products that rely on CRISPR-Cas9 technology, the rapidly developing field has already grabbed the attention of the US Food and Drug Administration (FDA) and other drug regulators.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, Europe, FDA, EMA Tags: CRISPR-Cas9, CRISPR regulation, FDA and CRISPR, Editas, Intellia, CRISPR Therapeutics
Gottlieb Looks to Boost Generic Drug Competition

As the US continues to grapple with the high cost of prescription drugs, the Food and Drug Administration (FDA) on Wednesday announced plans to stop drugmakers from gaming the system to block generic competition.

Categories: Generic drugs, Submission and registration, News, US, FDA Tags: REMS, Competition, Generic Drugs
Regulatory Recon: Draft Drug Pricing Order Proposes to Ease Regulations; FDA Approves Shire's Long-Acting ADHD Drug (21 June 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Issues Draft Q&A on Electronic Systems in Clinical Investigations

The US Food and Drug Administration (FDA) on Tuesday issued a draft questions and answers guidance to clarify expectations for using electronic systems, including electronic records, cloud computing and mobile technology, in clinical investigations.

Categories: Clinical, News, US, FDA Tags: Electronic systems, Mobile technology
CBER Director Offers a Peek Into the Complexities of Where the Center is Headed

In addition to protecting the US blood supply and ensuring vaccines are safe and effective, the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) is also now regulating complex gene and cell therapies, as well as a new category of treatments: regenerative medicines.

Categories: Biologics and biotechnology, News, US, CBER Tags: CBER, CAR-T, hemophilia, Peter Marks
FDA Commissioner Vows to Eliminate Backlog of Orphan Drug Designation Requests

At a Senate hearing on President Donald Trump's FY2018 budget request for the US Food and Drug Administration (FDA), Commissioner Scott Gottlieb vowed to eliminate the backlog of orphan drug designation requests and said he will soon release "modern and risk-based" tools for assessing new treatments, especially for rare diseases and conditions with no effective treatments.

Categories: Generic drugs, Orphan products, News, US, FDA Tags: FY2018 Budget, Appropriations, Orphan Drug Designations, REMS, Scott Gottlieb
Asia Regulatory Roundup: J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal (20 June 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Asia, Oceania, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
Regulatory Recon:  Pamplona to Buy CRO Parexel for $5B; FDA Approves Melinta Antibiotic to Treat Skin Infections (20 June 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
CBO Releases Cost Estimate for User Fee Bill

The Congressional Budget Office (CBO) on Thursday released its cost estimate for the Senate's bill to reauthorize the US Food and Drug Administration's (FDA) user fee programs, saying the agency will need $1.2 billion in appropriations from 2018-2022 to implement changes brought on by the bill.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Medical Devices, Government affairs, Submission and registration, News, US, FDA Tags: CBO, User Fees, Reauthorization
US FDA Sees Major Spike in BA/BE Studies in India

In 2002, the US Food and Drug Administration (FDA) did not conduct any bioavailability (BA) or bioequivalence (BE) study inspections in India for generic drug applications. A little more than a decade later, and nearly half of all FDA's BA/BE study inspections are conducted on the subcontinent.

Categories: Generic drugs, Clinical, Crisis management, Government affairs, News, US, India, FDA, CDSCO Tags: BA and BE studies, bioequivalence, generic drugs from India
Priority Generic Drug Reviews: New FDA Draft Guidance

In preparation of its commitments under the second Generic Drug User Fee Amendments (GDUFA II), the US Food and Drug Administration (FDA) on Monday released a draft guidance laying out how sponsors can qualify for shorter review times for priority generic drugs.

Categories: Generic drugs, Submission and registration, News, US, FDA, Communication Tags: Priority Generics, ANDA, Pre-Submission Facility Correspondence, PFC
Regulatory Recon: Seattle Genetics Halts Trials Due to Patient Deaths; Novartis' Rituxan Biosimilar Gets EU Approval (19 June 2017)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
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