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.

Quality Metrics: FDA Outlines What Data to Submit

The technical reference document released Friday from the US Food and Drug Administration (FDA) provides recommendations to pharmaceutical companies on the submission of records and other information to support FDA’s calculation of quality metrics as part of the process validation lifecycle and pharmaceutical quality system (PQS) assessment.

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Due Diligence, Government affairs, Manufacturing, News, US, FDA Tags: FDA quality metrics, OPQ, drug quality
EMA Recommends Suspending Alkem Drug Over Flawed Studies

The European Medicines Agency (EMA) on Friday recommended suspending the marketing authorization of a drug made by Indian generic manufacturer Alkem Laboratories over data integrity issues at the company's bioequivalence facility in Taloja, India.

Categories: Generic drugs, Clinical, Submission and registration, News, Europe, India, EMA, MHRA Tags: Alkem, riluzone, Good Clinical Practice, GCP
Brexit Conundrum: How Does MHRA Work With EMA Moving Forward

With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent.

Categories: Drugs, Medical Devices, Government affairs, Postmarket surveillance, News, Europe, EMA, EC, MHRA, NICE Tags: Brexit, UK regulation of medicines, regulation of drugs after Brexit
Regulatory Recon: Brexit Fallout: How Will MHRA and EMA Handle the Split? (24 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News, EU Referendum, Brexit
Gavi Commits $27.5m to WHO Malaria Vaccine Candidate’s Pilot Program as More Funds Needed

The public-private vaccine alliance known as Gavi on Thursday pledged $27.5 million to a pilot project that the World Health Organization is running to introduce a malaria vaccine candidate into sub-Saharan Africa.

Categories: Biologics and biotechnology, Government affairs, Project management, Regulatory intelligence, Submission and registration, News, Africa, WHO Tags: Gavi, PATH, malaria vaccine, GSK, Gates Foundation
BIO Opposes House Bill to Reduce Biologics Exclusivity From 12 to 7 Years

Rep. Jan Schakowsky (D-IL) and three Democratic colleagues in the House took a jab at the biotech industry on Thursday, introducing a new bill that would reduce the amount of exclusivity for biologics from 12 years to seven years.

Categories: Biologics and biotechnology, Due Diligence, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: biologics exclusivity, biosimilars, BPCIA, market exclusivity
Faulty Filter Prompts Recall of Leukocyte Reduction Device

The US Food and Drug Administration (FDA) on Thursday warned healthcare providers that a faulty filter in recently distributed lots of Haemonetics' Leukotrap RC System can result in higher than acceptable leukocyte counts in blood used in transfusions.

Categories: Blood, Product withdrawl and retirement, News, US, CBER Tags: Haemonetics, Leukotrap
New Report Calls on FDA to Clarify Use of Real-World Evidence

As legislation to speed the process by which the US Food and Drug Administration (FDA) approves new drugs and devices continues to stall in Congress, mostly because of disagreement over funding for the National Institutes of Health (NIH) and patient safety concerns, a nonprofit on Thursday released a new report calling for FDA to clarify ways real-world evidence can be used to support clinical trials and postmarket commitments.

Categories: Drugs, Medical Devices, Clinical, Government affairs, Postmarket surveillance, Product withdrawl and retirement, News, US, FDA Tags: real world evidence, FDA Commissioner, Robert Califf, Patrick Soon-Shiong, Duke University
European Regulatory Roundup: EC to Let MAHs Delegate Certain Falsified Medicines Directive Tasks to Third Parties (23 June 2016)

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

Categories: Active pharmaceutical ingredients, Drugs, Compliance, Due Diligence, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC Tags: API imports, MAHs, IVD
Regulatory Recon: Republicans Approve $1.1Bn to Fight Zika; UK Votes on 'Brexit' Today (23 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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 Backs Five New Drugs, Gives Conditional Recommendation to GSK's Benlysta

The UK's National Institute for Health and Care Excellence (NICE) on Wednesday issued recommendations for six drugs after agreeing to discounts with their respective manufacturers, clearing the drugs for use by the country's National Health Service (NHS).

Categories: Biologics and biotechnology, Drugs, Reimbursement, Submission and registration, News, Europe, NICE Tags: Zykadia, Mekinist, Praluent, Repatha, Humira, Benlysta, NICE, NHS
FDA Offers Regional Specifications on Submission of ICSRs for Drugs and Biologics

The US Food and Drug Administration (FDA) on Wednesday released the technical specifications to assist interested parties in electronically submitting individual case safety reports (ICSRs) and ICSR attachments to its Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

Categories: Biologics and biotechnology, Drugs, Postmarket surveillance, Quality, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: ISCRs, ICH, eCTD, E2B(R3)
FDA Warns Medtronic Subsidiary Over Adulterated Devices

Highlighting validation concerns and the distribution of adulterated devices with nonconformities, the US Food and Drug Administration (FDA) earlier this month sent a warning letter to Medtronic subsidiary Tyrx.

Categories: Medical Devices, Compliance, Manufacturing, News, US, FDA Tags: Medtronic, absorbable mesh, antibacterial envelope, device warning letter
Obama Signs Chemical Safety Bill Into Law

President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US.

Categories: Crisis management, Manufacturing, Quality, News, US Tags: TSCA, chemical safety, new chemicals law
FDA Pilot Project to Test New Import Communication System

The Food and Drug Administration (FDA) on Wednesday said it intends to conduct a pilot program to test and evaluate a new Import Trade Auxiliary Communication System (ITACS) and is seeking participants.

Categories: Drugs, Compliance, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: ITACS, ACE, imports and FDA
EMA and FDA Begin Collaborations on Patient Engagement

The European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on Wednesday began exchanging more information on the best practices of involving patients in the development, evaluation and post-authorization tracking of medicines.

Categories: Drugs, Postmarket surveillance, Research and development, Regulatory strategy, Regulatory intelligence, News, US, Europe, FDA Tags: EMA cluster, patient engagement, drug regulators working with patients
Regulatory Recon: Medicare Fund Will Run Out in 2028, IPAB Expected in 2017; A Look at Today's Immuno-Oncology Pipeline (22 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Senators, Experts Weigh Bipartisan Bill to Stop REMS Abuses

The Senate Judiciary Committee on Tuesday held a meeting with a panel of experts to discuss a recently introduced bill that seeks to stop branded drug companies from misusing Risk Evaluation and Mitigation Strategies (REMS) to withhold access to drug samples for bioequivalence testing necessary for bringing generic drugs to market.

Categories: Drugs, News, US, FDA Tags: CREATES Act, REMS, Senate Judiciary
FDA Warns Questionable Cancer Clinic Again for CGMP Violations

A little more than a month after the US Food and Drug Administration (FDA) was overruled by a judge to allow a college student with terminal cancer to re-start a clinical trial, in which he’s the only patient, FDA has issued a warning letter to the manufacturing facility linked to the trial, noting serious current good manufacturing practice (CGMP) violations.

Categories: Drugs, Government affairs, Manufacturing, News, US, FDA Tags: Burzynski, antineoplastons, warning letter
FDA Withdraws Document Calling on Biosimilar Developers to Submit 10 Random Suffixes

The US Food and Drug Administration (FDA) on Tuesday withdrew a document submitted to the Office of Management and Budget (OMB) that offered new details on how biosimilar developers would submit an ordered list of 10 random suffixes as part of the naming process for new biosimilars.

Categories: Biologics and biotechnology, Government affairs, Labeling, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA Tags: biosimilar names, biosimilar suffixes
Regulatory Recon: NIH Refuses to 'March-In' on Xtandi; Billionaire Sean Parker Funds First In-Human CRISPR Trial (21 June 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

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: CFDA Offers Guidance on Revised Vaccine Distribution Regulations (21 June 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 Tags: vaccine distribution in China, FDC manufacturers in India, NPPA
NIH Finalizes Single IRB Policy to Reduce Redundancies

The National Institutes of Health (NIH) on Monday finalized a policy that will require NIH-funded clinical studies to be overseen by a single institutional review board (sIRB), beginning in May of next year.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US Tags: Single Institutional Review Board, sIRB, Single IRB
Updated: Biosimilars in the US: Panel Discusses Tricky Balance of Building the Market With Necessary Precautions

Biosimilar experts, including the US Food and Drug Administration's (FDA) Dr. Leah Christl and biosimilar developer Coherus Biosciences' chief medical officer Dr. Barbara Finck, sat down on Monday at an Alliance for Health Reform event to discuss the challenges the US faces in developing a robust biosimilars market and also ways the US can avoid fear mongering and increase uptake.

Categories: Biologics and biotechnology, Clinical, Government affairs, Research and development, Quality, News, US, CBER Tags: biosimilars, interchangeability, BPCIA
FDA Finalizes Guidance on Extrapolating Data for Pediatric Medical Devices

A little more than a year after introducing the draft version, the US Food and Drug Administration (FDA) on Monday finalized guidance on how and when it may be appropriate to leverage existing clinical data to support pediatric device indications and labeling.

Categories: Medical Devices, Clinical, Research and development, Regulatory strategy, Regulatory intelligence, News, US, CDRH Tags: pediatric medical devices, medical device clinical data
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