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.

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
FDA Offers Updated Form for Field Alert Reports

The US Food and Drug Administration (FDA) on Thursday released an updated version of its automated Field Alert Report (FAR) form, following the conclusion of a successful four-year pilot program.

Categories: Prescription drugs, Generic drugs, Postmarket surveillance, News, US, FDA Tags: FAR, Field Alert Reports
Trump Administration Officials Huddle at White House to Discuss Drug Pricing

A White House spokesman confirmed to Focus that a meeting took place at the White House on Friday "as part of the ongoing discussions to reduce the burden of the high cost of drug prescriptions and unleash a wave of innovation to develop cures and treatments for patients."

Categories: Drugs, News, US, FDA Tags: Trump, drug pricing, White House meeting on drug prices
FDA Extends Use Dates for Pfizer Injectables to Ease Shortage

The US Food and Drug Administration (FDA) on Thursday said it is extending the use dates of multiple lots of injectable drugs made by Pfizer subsidiary Hospira by six months to a year in response to an ongoing shortage of the drugs.

Categories: Drugs, Distribution, Manufacturing, News, US, FDA Tags: Pfizer, Hospira, Shortage
WHO to Craft Essential Diagnostics List

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: In vitro diagnostics, Medical Devices, Due Diligence, Government affairs, Regulatory strategy, Regulatory intelligence, News, Canada, Europe, Asia, Latin America and Caribbean, Africa, Middle East, Oceania, WHO Tags: WHO essential diagnostics, EDL, Essential medicines list
Application of EU Clinical Trial Regulation Delayed to 2019

The European Medicines Agency’s management board said that due to technical difficulties with the development of IT systems, the application of the clinical trial regulation has to be postponed.

Categories: Clinical, Compliance, Government affairs, News, Europe, EMA, EC Tags: EMA clinical trial regulation, clinical trial regs, EMA portal
Regulatory Recon: Adamis Wins FDA Approval for EpiPen Rival; BMS to Sell Ireland API Plant to SK Biotek (16 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
NICE, Roche Reach Deal on Breast Cancer Drug

Patients in the UK could soon get access to Roche's targeted breast cancer drug Kadcyla (trastuzumab emtansine) through the National Health Service (NHS) as early as next month, the National Institute for Health and Care Excellence (NICE) said on Thursday.

Categories: Biologics and biotechnology, Reimbursement, News, Europe, NICE Tags: NICE, Roche, Kadcyla, Herceptin, Trastuzumab
European Regulatory Roundup: ENVI Urges EC to Exclude Healthcare From Regulation of Professions (15 June 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, ENVI, antibiotics, PRAC
Regulatory Recon: Google, Novartis Back Medicxi's $300M Biotech Fund; China's Rise in Biotech (15 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 Pilot to Sign Off on Low-Risk Digital Health Products Without Premarket Review

US Food and Drug Administration (FDA) Commissioner Scott Gottlieb on Thursday announced an upcoming pilot program that would create a third-party certification program under which lower-risk digital health products could be marketed without FDA premarket review and higher-risk products could be marketed with a streamlined FDA review.

Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: digital health, FDA digital health, software as a medical device
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