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: Amsterdam HQ Won't Be Ready in Time for Move

The European Medicines Agency (EMA) on Friday said that its new headquarters in Amsterdam will not be complete until November 2019, eight months after the agency must move from its current offices in London.

Categories: Drugs, Government affairs, News, Europe, EMA, MHRA Tags: Relocation, Brexit, Amsterdam, EMA HQ
FDA Offers Two New Draft Guidances on Developing Targeted Therapies

The US Food and Drug Administration (FDA) on Friday published two new draft guidance documents that seek to support the development of treatments that address the underlying genetic mutations that often cause or contribute to diseases and another discussing how to determine if an in vitro diagnostic (IVD) device used in a study must undergo its own FDA review, distinct from the drug study.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Clinical, Compliance, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: tumor agnostic approvals, investigational IVDs, genetic mutation
Regulatory Recon: FDA Lifts Hold on Alnylam Hemophilia Trials; EMA Recommends 7 New Medicines for EU Approval (15 December 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 to Begin Issuing Deficiency Review Letters to Generic Drugmakers

The US Food and Drug Administration (FDA) on Friday published draft guidance that would establish a new type of letter the agency sends to generic drugmakers to provide applicants with preliminary thoughts on possible deficiencies of an abbreviated new drug application (ANDA).

Categories: Generic drugs, Compliance, Government affairs, Quality, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: DRLs, CRLs, information requests, GDUFA II
European Regulatory Roundup: Critical Moment for EMA (15 December 2017)

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

Categories: Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC Tags: European Regulatory Roundup, Brexit, pediatric rare disease
What's Coming in 2018: FDA's Regulatory Agenda

The US Food and Drug Administration (FDA) published its fall 2017 agenda of proposed and final rulemakings this week, with several expected on drug compounding, allowing foreign clinical data to bring medical devices to market and new ways to market nonprescription drugs.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: proposed rulemaking, final rulemaking, regulatory agenda
FDA Discusses Device Least Burdensome Provisions in New Draft Guidance

After signaling that it would shift more of the regulatory oversight of medical devices to the postmarket setting, the US Food and Drug Administration (FDA) on Thursday issued a new draft guidance detailing updates to its least burdensome approach to regulating devices.

Categories: Medical Devices, Clinical, Postmarket surveillance, Preclinical, Submission and registration, News, US, CDRH Tags: Least Burdensome, FDASIA, 21st Century Cures, Alternative 510(k) Pathway
FDA to Pharma Firms: Update or Certify Drug Listings by End of Month

To ensure the National Drug Code directory is accurate, the US Food and Drug Administration (FDA) on Thursday sent a reminder to pharmaceutical companies that 31 December 2017 is the deadline by which the firms must update or certify their drug listings with FDA via electronic format.

Categories: Drugs, Compliance, Due Diligence, News, US, FDA Tags: drug listings, Part 207 of Title 21
Pfizer Not Planning US Launch of its Second Remicade Biosimilar Approved by FDA

The US Food and Drug Administration (FDA) late Wednesday approved the ninth biosimilar in the US and the third for J&J’s Remicade (infliximab), but Pfizer said it will not launch Ixifi (infliximab-qbtx) in the US as the company already has another Remicade biosimilar on the market and known as Inflectra (infliximab-dyyb) (the third Remicade biosimilar is Merck and Samsung Bioepis’ Renflexis (infliximab-abda)).

Categories: Biologics and biotechnology, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: Pfizer, Inflectra, Remicade, J&J, Ixifi
Regulatory Recon: Months After Approval, Gilead's Yescarta Has Treated Just Five Patients; Teva to Cut 14,000 Jobs (14 December 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
Antimicrobial Susceptibility: FDA Launches Test Website, Issues Guidance

The US Food and Drug Administration (FDA) on Wednesday launched a new website aimed at improving access to information that can help healthcare professionals determine which drugs are most likely to work to treat bacterial or fungal infections.

Categories: Drugs, In vitro diagnostics, Labeling, News, US, FDA Tags: Antimicrobial Susceptibility Interpretive Test Criteria, Breakpoint, 21st Century Cures
Medtronic Settles Deceptive Advertising Lawsuit for $12M

State attorneys general in Massachusetts, Oregon, California, Illinois and Washington on Wednesday announced a $12 million multistate settlement with Medtronic to resolve claims the company deceptively marketed one of its devices known as Infuse.

Categories: Medical Devices, News, US, Advertising and Promotion Tags: Medtronic, Infuse, deceptive marketing
Updated: Generic Drug Monthly Dashboard: FDA Adds New Metrics

The US Food and Drug Administration (FDA) last month began releasing new information a monthly basis related to generic drugs.

Categories: Generic drugs, News, US, FDA Tags: generic drug activity, GDUFA II
Regulatory Recon: Teva Said to Reveal Restructuring Plan Thursday; Sanofi Looks to Pipeline to Offset Recent Setbacks (13 December 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 Korean OTC Drugmaker Using Noncompliant Contract Manufacturer

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns.

Categories: Over the counter drugs, Quality, News, US, Asia, FDA Tags: Coko Loko, Legal Lean Syrup, Seindni
FDA Issues Draft Guidance on Gluten Labeling for Drugs

The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance encouraging drugmakers to provide detailed labeling about whether their products are made from ingredients that contain gluten.

Categories: Drugs, News, FDA Tags: Gluten, Gluten-Free, Labeling
CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017.

Categories: In vitro diagnostics, Medical Devices, Clinical, Postmarket surveillance, News, CDRH Tags: patient-reported outcomes, medical device submissions
Congress Looks to Delay Medical Device Tax by 5 Years

The House GOP are looking to bring together an 11th-hour fix to stop a tax on medical device companies from taking force as of 1 January 2018.

Categories: Medical Devices, Government affairs, News, US Tags: device tax, AdvaMed
Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017)

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

Categories: Drugs, Compliance, Government affairs, News, Asia, Oceania, TGA Tags: Asia Regulatory Roundup, ACSS, GSK, Novartis
When Can FDA 'Refuse to File' NDAs and BLAs? New Draft Guidance Explains

When a new drug application (NDA) or biologics license application (BLA) is deemed incomplete by the US Food and Drug Administration (FDA), the agency can decide not to review the application. So when can this occur? On Tuesday, the agency released draft guidance on what incompleteness means and when it can lead to a "refusal to file" decision.

Categories: Biologics and biotechnology, Drugs, Compliance, Due Diligence, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: refuse to file, NDA, BLA, FDA draft guidance
Regulatory Recon: FDA Approves First Drug for Eosinophilic Granulomatosis with Polyangiitis; Allergan Acquires Ailing Repros (12 December 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 Finalizes Guidance on Promotional Drug Labeling and Ads

The US Food and Drug Administration (FDA) on Monday finalized guidance from 2013 on prescription drug product name placement, size, prominence and frequency in promotional labeling and advertisements for human prescription drugs.

Categories: Drugs, News, US, FDA, Advertising and Promotion Tags: drug labeling, promotional and advertising guidance FDA, deceptive pharma ads
French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials

France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials.

Categories: Biologics and biotechnology, Drugs, Clinical, News, Europe, EMA Tags: First-in-Human, Clinical Trials, ANSM, Bial
What New CDRH Guidance is Coming in FY 2018: Alternative 510(k) Pathway and More

While recognizing that comparison testing for 510(k) applicants can be outdated, especially for newer medical devices, the US Food and Drug Administration (FDA) announced Monday that in the first quarter of 2018, new draft guidance will be released to address an alternative pathway for demonstrating substantial equivalence.

Categories: In vitro diagnostics, Medical Devices, Government affairs, Research and development, News, US, CDRH Tags: CDRH guidance, 510(k) alternative pathway, PMA
Regulatory Recon: News From ASH 2017; Drugmakers Sue to Block Calif. Price Law (11 December 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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