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 Weighs Limited Risk Info in DTC Ads

The US Food and Drug Administration (FDA) on Friday announced it is considering a new approach to presenting risk information in direct-to-consumer (DTC) television and radio ads that would allow drugmakers to limit the amount of risks presented.

Categories: Biologics and biotechnology, Drugs, News, US, FDA, Advertising and Promotion Tags: Advertising, DTC, Risk, Major Statement
FDA Offers Draft Guidance to Further Secure Drug Supply Chain

The US Food and Drug Administration (FDA) has released draft guidance ahead of the first of a series of public meetings to help companies meet the drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) of 2013.

Categories: Biologics and biotechnology, Drugs, Distribution, Labeling, Packaging, Regulatory strategy, News, US, FDA Tags: DSCSA, track and trace, FDA guidance, drug supply chain
Regulatory Explainer: FDA User Fee Reauthorizations From 2018 to 2022

President Donald Trump late Friday signed a bill that reauthorizes the US Food and Drug Administration (FDA) user fee programs for prescription drugs, generic drugs, biosimilars and medical devices through 2022.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: FDARA, FDA user fees, user fee reauthorization, medical product reviews
Regulatory Recon: Samsung Bioepis and Takeda Team Up for Biologics Development; Hikma Raises Prices of Six US Generics (21 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 Explains Emergency Expanded Access Application Process

The US Food and Drug Administration (FDA) has laid out the process by which doctors can access an investigational drug for treatment use in an individual patient in an emergency situation, both during and after normal business hours in a new Manual of Policies and Procedures.

Categories: Drugs, Crisis management, Government affairs, News, US, FDA Tags: expanded access, Right to Try, emergency IND
FDA Singles Out Biologics Company for Failing to Meet Pediatric Study Requirement

The US Food and Drug Administration (FDA) has determined that Organogenesis, Inc. has failed to meet the postmarketing requirement of the Pediatric Research Equity Act (PREA) for its Biologics License Application (BLA) for Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen (GINTUIT).

Categories: Biologics and biotechnology, Clinical, News, US, FDA Tags: PREA, FDASIA, non-compliance letters FDA
Protalex Wins $403K Grant from FDA Office of Orphan Products Development

Clinical-stage biopharma Protalex, Inc. on Thursday said it has been awarded a $403,000 grant from the US Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) to support future clinical development activity of PRTX-100 as a treatment for immune thrombocytopenia (ITP).

Categories: Drugs, Orphan products, Clinical, News, US, FDA Tags: OOPD, orphan drug, Protalex
Congressmen Investigate 'Shadow Pricing' of MS Drugs

Democratic Reps. Elijah E. Cummings (MD) and Peter Welch (VT) on Thursday sent letters to seven pharmaceutical companies requesting information about the skyrocketing prices for drugs used to treat multiple sclerosis (MS).

Categories: Drugs, Crisis management, News, US Tags: MS drug prices, Teva, Bayer, Welch
European Regulatory Roundup: Ireland Starts Consultation on Biosimilar Policy (17 August 2017)

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

Categories: Biologics and biotechnology, Drugs, News, Europe, EMA, EC Tags: European regulatory roundup, Ireland biosimilars, CROs
Professors Offer 3 Questions on FDA’s New Digital Health Framework

The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs, who offer up three questions about the direction of the plan.

Categories: Medical Devices, Government affairs, News, US, FDA Tags: digital health, pre-certification pilot
Mylan Settles With DOJ for $465M Over EpiPen Medicaid Rebates

Drugmaker Mylan announced on Thursday that it will pay $465 million to settle claims relating to the classification of EpiPen auto-injectors and EpiPen Jr. auto-injectors because of allegations of a misclassification of the product in the Medicaid Drug Rebate Program. 

Categories: Drugs, Medical Devices, News, US, DOJ Tags: EpiPen, Mylan, Medicaid
Regulatory Recon: Novo Diabetes Drug Succeeds in Key Trial; Generic Drugmakers Feel Pinch as Prices Crumble (17 August 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, Europe, Asia, FDA, EMA, EC, MHRA Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
ICH Details Pilot Training Programs for 2017

The International Council for Harmonization (ICH) has released details for five upcoming training programs in the US, Germany and Japan.

Categories: Drugs, Clinical, Manufacturing, Submission and registration, News, US, Europe, Japan, ICH Tags: ICH, Training, eCTD, GMP, GCP
PhRMA Criticizes FDA's 'Unnecessary' Research on Drug Advertising and Promotion

The pharmaceutical industry lobbying group known as the Pharmaceutical Research and Manufacturers of America (PhRMA) is harshly criticizing the US Food and Drug Administration's (FDA) research focused on prescription drug advertising and promotion and calling for a clearer vision on how this research protects public health.

Categories: Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory strategy, News, US, FDA, Advertising and Promotion Tags: PhRMA, drug advertising and promotion, FDA research
Regulatory Recon: BMS Sees Mixed Results for Opdivo, Yervoy Combo in Kidney Cancer; South Carolina Sues Purdue Over Opioid Marketing (16 August 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 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
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
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
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
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