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.

EU Court of Justice Clarifies Product Liability for Notified Bodies

The European Court of Justice (ECJ) last week issued its long-awaited judgement on a case that heavily influenced the new revisions of the EU's Medical Device Directives.

Categories: Medical Devices, Quality, News, Europe, EC Tags: European Court of Justice, TÜV Rheinland, PIP Breast Implants, Notified Bodies
Regulatory Recon: FDA Warns Pfizer's Kansas Site; AstraZeneca Sells Zoladex Rights for $250M (20 February 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
Biosimilars Council Urges Supreme Court to Reject Additional Six Months Exclusivity for Biologics

In an amicus brief filed on Friday, the Biosimilars Council, a division of the newly rebranded Association for Accessible Medicines (previously the Generic Pharmaceutical Association), argues that the US Supreme Court should not give biologic manufacturers an additional six months of market exclusivity beyond the “already-generous twelve years” granted.

Categories: Biologics and biotechnology, Government affairs, Research and development, Submission and registration, News, US Tags: biosimilars, GPhA, AAM, Biosimilars Council, Amgen, Sandoz
Genentech Files Complaint Over Amgen’s Development of Avastin Biosimilar

Roche’s Genentech filed a complaint in Delaware District Court last week charging that Amgen, which is developing a biosimilar version of Genentech’s blockbuster cancer treatment Avastin (bevacizumab), has obstructed its ability to determine whether the manufacture and/or sale of Amgen’s biosimilar would infringe Genentech’s patents.

Categories: Biologics and biotechnology, Compliance, Regulatory intelligence, Submission and registration, News, US, FDA Tags: Genentech, Roche, Avastin, Amgen, biosimilars
EC Will Not Offer a Timeline for Phasing Out Non-Human Primate Research

The European Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) released a preliminary opinion earlier this month reiterating the consensus that, when alternatives do not exist, appropriate use of non-human primates (NHPs) remains essential to some biomedical and biological research, as well as for the safety assessment of pharmaceuticals.

Categories: Drugs, Human cell and tissue, Medical Devices, Crisis management, Compliance, Ethics, Government affairs, Preclinical, News, Europe, EC Tags: animal research, drug safety testing, non-human primates, European Commission Opinion
FDA Explains Why Newly Approved Biologic’s Name Lacks a Suffix

The US Food and Drug Administration (FDA) approved a new biologic this week, but its name did not adhere to recently finalized guidance calling for all new and previously approved biologics and biosimilars to have a four-letter random suffix attached to their nonproprietary names.

Categories: Biologics and biotechnology, News, US, FDA Tags: Valeant, Siliq, nonproprietary names of biologics, biosimilars
Transparency Push: EMA to Revise Policy on Document Access

The European Medicines Agency (EMA) on Friday proposed a revision to its policy on accessing documents, extending the scope to include corporate documents, and increasing the publication of clinical data for pharmaceuticals.

Categories: Biologics and biotechnology, Drugs, Clinical, Due Diligence, Government affairs, News, Europe, EMA, EC Tags: pharmaceutical data transparency, EMA transparency
Regulatory Recon: Rep. Cummings Wanted to Talk Drug Prices With Trump; ANVISA Developing New Device Regulations (17 February 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
CTTI Offers Recommendations for Pediatric Clinical Trials for Antibiotics

The Clinical Trials Transformation Initiative (CTTI) has released a set of recommendations it says will improve the use of antibiotics in children.

Categories: Drugs, Clinical, News, FDA, EMA Tags: Pediatric clinical trials, Antibacterial, Antibiotics, CTTI, Clinical Trials Transformation Initiative
GAO: FDA's Ability to Monitor Drug Shortages Remains a Concern

The US Food and Drug Administration's (FDA) oversight of medical products remains a high-risk area for the federal government, particularly with regard to the agency's oversight of drug shortages, according to a report from the Government Accountability Office (GAO) released Wednesday.

Categories: Drugs, Postmarket surveillance, News, US, FDA Tags: GAO, Government Accountability Office, Drug Shortages
EMA Weighs New Guideline on Quality Requirements for Combination Products

The European Medicines Agency (EMA) on Thursday released for public consultation a new concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product.

Categories: Combination products, Quality, News, Europe, EMA Tags: combination products, notified bodies, quality requirements
House Bill Seeks to Add Mandatory Drug Recall Authority to FDA’s Arsenal

Rep. Rosa DeLauro (D-CT) on Thursday introduced a new bill that will allow the US Food and Drug Administration (FDA) to do what many assume it already can: Require pharmaceutical or over-the-counter drug companies to stop marketing unsafe products.

Categories: Drugs, Product withdrawl and retirement, Regulatory strategy, Regulatory intelligence, US, FDA Tags: DeLauro, mandatory drug recall, FDA authority, drug recalls, homeopathic
Industry Groups Petition FDA Over Revisions to ‘Intended Use’ Rule

The Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have petitioned the US Food and Drug Administration (FDA) following its “unexpected decision” last month to revise the definitions of “intended use” for drugs and medical devices.

Categories: Drugs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: PhRMA, BIO, intended use, Allergan, rulemakings
Regulatory Recon: Broad Triumphs in CRISPR Patent Dispute; FDA Approves Valeant Psoriasis Drug Siliq (16 February 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
European Regulatory Roundup: House of Lords Backs Change to Drug Pricing Bill to Appease Pharma Industry (16 February 2017)

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

Categories: Biologics and biotechnology, Government affairs, News, Europe, EMA, EC, MHRA, Business and Leadership Tags: European regulatory roundup, biosimilars, Brexit
FDA Warns Fresenius Kabi Subsidiary Over Promotional Materials

The US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has warned Fenwal, a Fresenius Kabi subsidiary, for the second time due to promotional materials for the company's platelet additive solution.

Categories: Blood, Drugs, Compliance, News, US, CBER, Advertising and Promotion Tags: Fenwal, Fresenius Kabi, InterSol, Amicus, Promotional Materials
China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: Biologics and biotechnology, Drugs, Clinical, Compliance, Government affairs, News, China, CFDA Tags: CFDA, clinical trials in China, drug approvals in China
AbbVie, Novartis Criticize FDA’s Guidance on Nonproprietary Names for Biologics and Biosimilars

Biopharmaceutical companies Novartis and AbbVie are taking issue with the US Food and Drug Administration’s (FDA) burdensome plan to require retroactive changes to the nonproprietary names of existing biologics and biosimilars, according to comments sent to the agency this week.

Categories: Biologics and biotechnology, Compliance, Labeling, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: biosimilars, nonproprietary names for biosimilars, nonproprietary names for biologics, FDA guidance
Regulatory Recon: Merck's Lead Alzheimer's Candidate Fails in Late Stage Study; EU Ready for First Cancer Biosimilars (15 February 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 Revises Bioequivalence Guidance for Generic Durezol Following Novartis Petition

The US Food and Drug Administration (FDA) on Tuesday revised its draft bioequivalence (BE) guidance detailing the agency's expectations for generic versions of Durezol (difluprednate ophthalmic emulsion) in response to a citizen petition from Alcon and its parent company Novartis.

Categories: Generic drugs, Submission and registration, News, US, FDA Tags: Durezol, Difluprednate Ophthalmic Emulsion, Alcon, Novartis, Citizen Petition, Bioequivalence
Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016)

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

Categories: Biologics and biotechnology, Drugs, Government affairs, Manufacturing, News, Asia, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, drug shortage, GMP inspection, India online portal
CDRH and CDER Send Warning Letters to Six Asian Companies

The flurry of US Food and Drug Administration (FDA) warning letters continued on Tuesday with the release of six new warning letters for pharmaceutical and medical device companies in China, India, Taiwan and Japan.

Categories: Active pharmaceutical ingredients, Drugs, Medical Devices, Government affairs, Manufacturing, Quality, News, US, Asia, FDA Tags: warning letters, China drug manufacturing, India drug manufacturing
EMA Reviews Safety of PAH Medicine Following 5 Deaths in France

The European Medicines Agency (EMA) signaled Tuesday that doctors can continue to use Actelion Pharmaceuticals’ pulmonary arterial hypertension (PAH) medicine Uptravi (selexipag) while the agency’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluates its safety following the deaths of five patients taking the medicine in France.

Categories: Drugs, Crisis management, Government affairs, News, Europe, EMA Tags: Uptravi, PRAC, Actelion
Senators Call on HHS to Allow Canadian Drug Imports if Prices Spike

Sens. Charles Grassley (R-IA), John McCain (R-AZ) and Amy Klobuchar (D-MN) on Tuesday sent a letter to Tom Price, the newly confirmed secretary of the Department of Health and Human Services (HHS), calling on him to fast-track the approval of prescription drugs imported from Canada in four different circumstances, including if the price of a drug increases significantly.

Categories: Drugs, Crisis management, Government affairs, News, US, FDA Tags: Klobuchar, McCain, Grassley, Canada drug imports, drug prices
Regulatory Recon: Califf Speaks Out on Speeding Approvals, FDA Staffing; US Panel Backs CRISPR Use in Human Embryos to Avoid Serious Disease (14 February 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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