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.

FDA Warns Chinese Manufacturer for GMP, Training Issues

The US Food and Drug Administration (FDA) has warned Chinese manufacturer Foshan Flying Medical Products for testing and validation issues at its Guangdong, China facility.

Categories: Over the counter drugs, Compliance, News, US, China, FDA Tags: Warning Letter, GMP
Regulatory Recon: Early Looks at Trial Results Giving Investors Whiplash; Biosimilars Still Hard to Sell Against Rivals (15 August 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
Studies Raise Questions on Trial Designs for New Drugs, Devices Sped to Market

Two new articles and an accompanying editorial from former US Food and Drug Administration (FDA) commissioner Robert Califf published Tuesday in JAMA raise questions about the risks of speeding new drugs and medical devices to market without enough preliminary evidence that they are effective.

Categories: Drugs, Medical Devices, Ethics, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: surrogate measures, accelerated approval, high-risk devices, Rob Califf
Asia Regulatory Roundup: No Manufacturers Have Complied With India's GMP Request (15 August 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, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, DCGI, GMP/GLP
How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs

As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards companies for developing products that the government purchases and often pays to develop.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: priority review vouchers, biodefense, medical countermeasures
EMA’s CHMP Adopts Updated Guideline on Manufacture of Finished Dosage Form

The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) on Monday adopted an updated guideline on what manufacturing process information should be included in the marketing authorization application (MAA).

Categories: Drugs, Manufacturing, Regulatory intelligence, News, Europe, EMA, EC Tags: CHMP, finished dosage form, pharmaceutical manufacturing
Apple Continues Push Into Device Industry With New Patent Filing

Last week, tech behemoth Apple signaled its interest in further pursuing the development of medical devices with a new patent granted for an electronic device that "computes health data."

Categories: In vitro diagnostics, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, CDRH Tags: Apple, iPhone, mHealth, digital health
Regulatory Recon: FDA Restricts Foreign Scientist Hirings; Trump Blasts Merck CEO for Quitting Council (14 August 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 Considers WHO Scheduling Change for 17 Drug Substances

The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs.

Categories: Drugs, Crisis management, Government affairs, News, US, FDA, WHO Tags: drug substances, fentanyl, opioids, cannabis
Regulatory Recon: Trump Labels Opioid Crisis a National Emergency; FDA Warns of Deaths With Intragastric Balloons (11 August 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
New Research Compares Drug Regulators Around the Globe

Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of various regulators’ budgets, staff, new drug approvals and timelines for approvals.

Categories: Government affairs, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, FDA, EMA, MHRA, PMDA, CFDA, Anvisa Tags: comparison of drug regulators, new drug approval times, drug regulator reviewers
Federal Circuit Dismisses Amgen Appeal on Pfizer's Epogen Biosimilar

The US Court of Appeals for the Federal Circuit on Thursday dismissed Amgen’s appeal related to a lawsuit over Pfizer’s Epogen (epoetin alfa) biosimilar.

Categories: Biologics and biotechnology, Compliance, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Epogen, epoetin alfa, complete response letter, Pfizer, Amgen
German Regulators Slam Dr. Reddy's Plant for Critical, Major Deficiencies

Regulators working for the Central Authority for Supervision of Medicinal Products in Bavaria have published a statement of non-compliance with good manufacturing practices (GMP) following an August inspection of a Hyderabad, India-based manufacturing site run by Dr. Reddy's Laboratories.

Categories: Drugs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, Europe, Asia, FDA, EC Tags: Dr. Reddy's, competent authorities, EudraGMDP
European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (10 August 2017)

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

Categories: Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC Tags: pharmacovigilance, DKMA, Swissmedic
Regulatory Recon: Grail Sees Hope for Liquid Biopsy; Study Finds Heart Drug Prescribing Slashed After Price Hikes (10 August 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 Warns of Bacterial Contamination in PharmaTech Liquid Drugs

The US Food and Drug Administration (FDA) on Wednesday warned patients and health care professionals not to use liquid drugs made by Florida-based contract manufacturing organization (CMO) PharmaTech LLC due to possible bacterial contamination.

Categories: Drugs, Labeling, Manufacturing, News, US, FDA Tags: PharmaTech, Burkholderia cepacia, B. cepacia, Recall
FDA Offers More Details on Digital Health Precertification Pilot

The US Food and Drug Administration (FDA) this week sought to answer some frequently asked questions regarding the roll out of its new precertification pilot program for digital health products, which is expected to begin 1 September and only include nine participants.

Categories: In vitro diagnostics, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: digital health, precertification pilot for digital health, FDA digital health
Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate

A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, FDA Tags: Priority Review, Accelerated Approval, Fast Track, Breakthrough Therapy
Qualifying Medical Device Development Tools: FDA Finalizes 2013 Guidance

The US Food and Drug Administration (FDA) on Wednesday finalized guidance first drafted in 2013 to formalize a program that qualifies medical device development tools (MDDT) for use in device development and evaluation programs.

Categories: In vitro diagnostics, Medical Devices, News, US, CDRH Tags: MDDT, medical device development tools, FDA guidance
Regulatory Recon: SoftBank Bets $1.1B on US Biotech Roivant; Mylan Delays Product Launches Over Uncertainty (9 August 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
Generic Drugs in 2017: FDA on Track for Most Approvals Ever

Ten months into Fiscal Year 2017 and the US Food and Drug Administration (FDA) is on pace to break its record-setting year for abbreviated new drug application (ANDA) approvals from the last year.

Categories: Generic drugs, Government affairs, Submission and registration, News, US, FDA Tags: generic drug approvals, ANDA approvals
FDA Drafts Guidance on Postapproval Manufacturing Changes for Biologics

As the number of chemistry, manufacturing and controls (CMC) postapproval manufacturing supplements continues to increase, the US Food and Drug Administration (FDA) on Tuesday released draft guidance offering recommendations for holders of biologics license applications (BLAs) on the types of minor changes to be documented in an annual report.

Categories: Biologics and biotechnology, Manufacturing, Postmarket surveillance, News, US, FDA Tags: BLA, CMC changes, postapproval manufacturing changes, FDA draft guidance
Proposed and Final FDA Rules: What’s Left in 2017

The US Food and Drug Administration (FDA) is planning to release seven proposed rules and six final rules to close out 2017, according to an updated list of Department of Health and Human Services rulemakings.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: FDA rulemakings, biologics manufacturing inspections, de novo, medical device rulemakings
EMA Reports Rise in Pharmacovigilance Inspections in 2016

In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs.

Categories: Biologics and biotechnology, Drugs, Compliance, Postmarket surveillance, News, Europe, EMA Tags: Pharmacovigilance, Pharmacovigilance Inspections
Asia Regulatory Roundup: CFDA Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (8 August 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Submission and registration, News, Asia, CFDA, TGA Tags: Asia Regulatory Roundup, China guidance
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