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: Priority Review Drugs Have Higher Likelihood of Getting Boxed Warning After Approval

A team of officials from the US Food and Drug Administration (FDA) say that drugs approved following a priority review are three-and-a-half times more likely to receive a boxed warning after entering the market.

Categories: Drugs, Labeling, Product withdrawl and retirement, News, US, FDA Tags: Boxed Warning, Priority Review
House Bill Seeks to Expand Off-Label ‘Scientific Exchange’ Between Industry, Doctors

While the US Food and Drug Administration (FDA) attempts to re-work its policy on off-label use communications, Rep. Morgan Griffith (R-VA) has introduced a new bill that would further allow pharmaceutical companies to discuss such uses with physicians.

Categories: Government affairs, News, US, FDA, Advertising and Promotion Tags: off-label communications, intended uses, scientific exchange, pharmaceutical policy
Pfizer Proposes to Make Viagra Available in the UK Without a Prescription

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has released a Pfizer proposal calling to make the popular erectile dysfunction drug sildenafil (more commonly known as Viagra) available without a prescription at UK pharmacies.

Categories: Over the counter drugs, News, Europe, MHRA Tags: Pfizer, Viagra, Cialis, over the counter drugs, erectile dysfunction
UK Triggers Brexit: What’s Next for the UK, MHRA and EMA?

UK Prime Minister Teresa May on Wednesday set in motion the UK’s departure from the EU over the next two years, guaranteeing the European Medicines Agency (EMA) will see some significant changes over the next few years.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA Tags: Brexit, EMA, MHRA, new EMA headquarters
HHS Secretary Working With Trump on a Plan to Reduce Drug Prices

Health and Human Services Secretary Tom Price told a House appropriations subcommittee on Wednesday that his agency is working with President Donald Trump on a plan to bring down the cost of pharmaceutical drugs.

Categories: Government affairs, News, US, FDA Tags: HHS appropriations, NIH, FDA, budget 2018
Regulatory Recon: FDA Approves New Drugs to Treat MS, Eczema (29 March 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
Regulatory Recon: FDA Approves Tesaro's Zejula for Ovarian Cancer; Trump Pushes Congress to Cut NIH 2017 Budget (28 March 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 Office of Regulatory Affairs Realignment to Begin in May

The US Food and Drug Administration's (FDA) Office of Regulatory Affairs (ORA), which carries out the agency's inspection program, will officially begin a major overhaul in the coming weeks, according to FDA's Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren.

Categories: Medical Devices, Compliance, News, US, FDA Tags: Office of Regulatory Affairs, Inspections, Jeffrey Shuren, House Energy & Commerce
Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017)

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

Categories: Biologics and biotechnology, Drugs, Crisis management, Government affairs, Regulatory strategy, Regulatory intelligence, News, Asia, CDSCO Tags: Asia regulatory roundup, fast-track approvals, combination products, antibiotic resistance
Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration

With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion.

Categories: Biologics and biotechnology, Drugs, Compliance, Government affairs, Quality, Regulatory strategy, Regulatory intelligence, News, US, Canada, Europe, Asia, FDA, APEC Tags: pharmaceutical supply chain, good manufacturing practices, good distribution practices, fake drugs
FDA Warns Singapore Ophthalmic Drug Manufacturing Site

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent 16 March to Singapore-based Opto-Pharm for its failure to address leaking containers and bottle defects, among other violations.

Categories: Drugs, Manufacturing, Regulatory strategy, News, US, FDA Tags: sterile eye wash, FDA warning letters
Diagnostics: Bipartisan Duo Offers Bill to Alter Regulations

The ongoing overhaul of diagnostic and lab-developed test (LDT) regulations turned another corner last week, with Reps. Larry Bucshon, M.D. (R-IN) and Diana DeGette (D-CO) releasing a discussion draft of a bill that would offer a new direction for the US Food and Drug Administration (FDA) and the Centers for Medicare & Medicaid Services (CMS).

Categories: In vitro diagnostics, Medical Devices, Government affairs, Postmarket surveillance, Research and development, News, US, FDA Tags: diagnostics, IVDs, IVCT, in vitro clinical test, LDT, lab-developed test
European Commission Recommends Changes to SmPC, Package Leaflets

The European Commission last week released a report detailing recommendations to improve the information provided to patients and healthcare professionals for approved drugs.

Categories: Drugs, Labeling, News, Europe, EMA, EC Tags: Summary of Product Characteristics, SmPC, Package Leaflet
Regulatory Recon: AZ's Tagrisso First to be Approved Under China's Priority Review Pathway; House Hearing on Device User Fees Set for Tuesday (27 March 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
Updated: Pharma Profits Continue to Dwarf R&D Spending as Pressure Mounts

With the repeal of Obamacare on life support, the furor over rising prescription drug prices and President Donald Trump’s support for the cause could end up filling the vacant crossroads where bipartisanship meets change.

Categories: Drugs, Business Skills, Government affairs, News, US Tags: drug company profits, drug prices, R&D spending on pharmaceuticals
House Committee Probes Restricted Distribution Systems Delaying Generics

The House Committee on Oversight & Government Reform on Wednesday heard testimony on how pharmaceutical companies use restricted distribution systems to delay generic drug competition.

Categories: Tags: REMS, Risk Evaluation and Mitigation Strategy, Restricted Distribution, Bioequivalence Studies
CDRH Seeks Participants for Staff Training Program

Medical device companies and other stakeholders have until 30 April to apply to be a part of the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP), which is meant to help agency staffers better understand medical devices. 

Categories: Combination products, In vitro diagnostics, Medical Devices, News, US, CDRH Tags: ELP, CDRH training, staff training FDA devices
EMA Calls to Suspend More Than 300 Drugs due to Unreliable Studies From Indian CRO

The European Medicines Agency (EMA) on Friday announced it is recommending the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies were conducted by Chennai, India-based contract research organization (CRO) Micro Therapeutic Research Labs.

Categories: Generic drugs, Compliance, Product withdrawl and retirement, Research and development, News, Europe, EMA, EC Tags: Indian CRO, CRO suspension, EMA suspension, generic drugs
Regulatory Recon: House Vote on Healthcare Bill Set for Friday Afternoon; Pfizer, German Merck mAb Gets First Approval for MCC (24 March 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
Updated: Duplicate MAAs: Amgen Wins EU-wide Approval for Two Humira Biosimilars

The European Commission (EC) on Thursday granted two marketing authorizations for Amgen’s biosimilars to AbbVie's blockbuster biologic Humira (adalimumab), known as Amgevita (adalimumab) and Solymbic (adalimumab).

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Submission and registration, News, Europe, EMA, EC Tags: Humira biosimilar, duplicate MAA, Amgen, Pfizer, Enbrel
FDA Issues Guidance on Drugs to Prevent Delayed Graft Function in Kidney Transplant Patients

The US Food and Drug Administration (FDA) on Wednesday issued new draft guidance detailing its expectations for drugs intended to treat delayed graft function (DGF) in kidney transplant patients.

Categories: Drugs, Clinical, Regulatory strategy, News, US, FDA Tags: Delayed Graft Function, DGF, Draft Guidance
MHRA Details Common Issues in Clinical Trial Applications

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Wednesday issued guidance detailing the most common issues it sees in clinical trial applications in an effort to help sponsors avoid unnecessary delays.

Categories: Biologics and biotechnology, Drugs, Clinical, News, Europe, MHRA Tags: Clinical Trial Applications, Validation
European Regulatory Roundup: EMA Reports Year-Long Shortage of BMS Kidney Transplant Drug; UK Rejects Indication-Specific Drug Pricing (23 March 2017)

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

Categories: Biologics and biotechnology, Drugs, Veterinary products, Reimbursement, News, Europe, EMA, EC, MHRA Tags: EU Regulatory Roundup, European Regulatory Roundup, Regulatory Roundup
Regulatory Recon: Fate of Health Care Act Uncertain as Vote Nears; GSK and Regeneron in Deal to Sequence Genes of 500,000 Britons (23 March 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
EMA Seeks Experts on Clinical Data Anonymization

The European Medicines Agency (EMA) on Wednesday issued a call for experts to join a new technical advisory group for anonymizing clinical data.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, News, Europe, EMA Tags: Clinical Study Reports, Publication, Transparency, Anonymization
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