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 Officials Defend Agency's Flexibility Under Current Regulatory Framework

Top officials at the US Food and Drug Administration (FDA) are defending the agency's flexibility to accelerate the availability of products by considering diverse data sources in product submissions.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Submission and registration, News Tags: Real-world data, Accelerated approval
EMA Adds Potential for Toe Amputation to SGLT2 Inhibitor Prescribing Info

The European Medicines Agency (EMA) on Friday noted the potential increased risk of lower limb amputation (mostly affecting the toes) in patients taking the SGLT2 inhibitors canagliflozin, dapagliflozin and empagliflozin for type 2 diabetes.

Categories: Drugs, News, Europe, FDA, EMA Tags: diabetes, amputation, SGLT2
FDA Office of Generics Points to Record-Setting 2016 Ahead of Next Week’s Hearing

While reporting a US savings of $1.68 trillion over the last 10 years for generic drugs, Kathleen Uhl, director of the US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD), also unveiled statistics for another record-setting year in generic drug approvals.

Categories: Generic drugs, News, US, FDA Tags: Office of Generic Drugs, GDUFA, BsUFA
Regulatory Recon: CHMP Recommends Six Medicines for Approval; FDA Panel Backs Sentinel Cerebral Protection System (24 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
Final Versions of EU MDR, IVD Released, Voting Begins Next Month

Device manufacturers looking to abide by the EU's new medical device and in vitro diagnostic regulations take note: The EU's overhaul of its framework is here.

Categories: In vitro diagnostics, Medical Devices, News, Europe, EC Tags:
FDA Discusses Upcoming Proposed Rule on One-Page Patient Medication Information

Officials from the US Food and Drug Administration (FDA) gathered on Thursday at DIA's advertising and promotion conference in Washington, DC, to discuss recent research, guidance for industry and enforcement action on pharmaceutical and medical device advertising and promotion.

Categories: News, US, FDA, Advertising and Promotion Tags: OPDP, Patient Medication Information, proposed rule
European Regulatory Roundup: EMA Recommends Approval of First Monoclonal Antibody Veterinary Medicine (23 February 2017)

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

Categories: Biologics and biotechnology, Drugs, Veterinary products, News, EMA, MHRA, Advertising and Promotion Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Regulatory Recon: First Biosimilar Cancer Treatment Approved in EU; Allergan CEO Pushes for Trump to Lead Pricing Talks (23 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 Continues to Reduce Generic Drug Backlog

The US Food and Drug Administration (FDA) on Wednesday revealed that it approved more than 700 abbreviated new drug applications (ANDAs) for generic drugs in 2016, though the number of ANDAs pending an industry response also rose by more than 700.

Categories: Generic drugs, Crisis management, Government affairs, News, US, FDA Tags: ANDA approvals, generic drug backlog, generic drug dashboard
Researchers Call on FDA to Follow EMA's Lead in Publishing Study Reports

Two researchers are calling on the US Food and Drug Administration (FDA) to follow the European Medicines Agency's (EMA) lead in proactively publishing clinical study reports.

Categories: Biologics and biotechnology, Drugs, Clinical, News, US, Europe, FDA, EMA Tags: Clinical Trial Transparency
Updated: TTIP on Thin Ice Not Likely to Delay US-EU Mutual GMP Recognition Deal

A deal to further harmonize and mutually recognize good manufacturing practice (GMP) inspections between the US and EU will not be delayed, as the EU ambassador to the US said Wednesday that the Transatlantic Trade and Investment Partnership (TTIP) is in a state of pause as there is no one within President Donald Trump’s administration with whom to continue discussions.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, Europe, FDA, EMA Tags: mutual GMP recognition, TTIP, EU-US trade deals
Regulatory Recon: PhRMA CEO Says FDA Review Process Should Remain the 'Gold Standard'; BMS Takeover Rumors Rise After Icahn Buys Stake (22 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
21st Century Cures Act Deadlines Approach in March and June

The massive 21st Century Cures Act, rushed to passage in the waning days of President Barack Obama’s presidency, features a whole host of provisions that will take years for the US Food and Drug Administration (FDA) and National Institutes of Health (NIH) to digest and implement, but it also includes several provisions that must be addressed by 13 March.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Government affairs, News, US, FDA, DOJ Tags: 21st Century Cures, Cures Act, NIH and Cures, clinicaltrials.gov, patient experience data and FDA
Senators Look to Overhaul Medical Device Inspections

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.

Categories: Medical Devices, Government affairs, News, US, CDRH Tags: Inspections
FDA’s Pazdur and Blumenthal: The March of Checkpoint Inhibitors Will Continue

More approvals of new immune-checkpoint inhibitors, targeted and personalized therapies, as well as the use of real-world evidence are coming in the near future, Richard Pazdur, director of the Office of Hematology and Oncology at the US Food and Drug Administration (FDA) and associate director Gideon Blumenthal wrote in a comment published this week in Nature.

Categories: Biologics and biotechnology, Drugs, Government affairs, Research and development, News, US, FDA Tags: oncology, Pazdur, Oncology Center of Excellence, FDA cancer drug approvals
EMA Outlines GCP Inspection Plan for 2017

The European Medicines Agency (EMA) on Tuesday released its 2017 work plan for good clinical practice (GCP) inspections, which involves collaborating with the US Food and Drug Administration (FDA) to limit duplicative inspections.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Regulatory strategy, Regulatory intelligence, News, Europe, EMA Tags: GCP guidelines, GCP inspections, trial site inspections
Asia Regulatory Roundup: India Applies Price Controls on Stents (21 February 2017)

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

Categories: Biologics and biotechnology, Drugs, Government affairs, News, Asia, CDSCO, TGA Tags: stents in India, substandard drugs, complementary medicines
Regulatory Recon: Amphastar Hit With CRL for Intranasal Nalaxone; NICE Rejects Ipsen's Cabometyx in Draft Guideline (21 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
Sarepta Sells Priority Review Voucher for $125M to Gilead

Sarpeta Therapeutics on Tuesday sold its priority review voucher (PRV) to Gilead for $125 million, speeding up the US Food and Drug Administration (FDA) approval process for any future drug or biologic of Gilead’s choosing from 10 months to six months.

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Sarepta, Gilead, priority review voucher, PRV, Cures
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
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