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.

Study Uses Real World Evidence to Replicate Pivotal Trial Results

A study published in JAMA Internal Medicine on Monday was able to replicate the results of a large randomized controlled clinical trial for the blood pressure drug telmisartan using real world evidence gathered from insurance claims data.

Categories: Drugs, News, US, FDA Tags: Real World Evidence
Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 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, CFDA, CDSCO, TGA Tags: Asia Regulatory Roundup, online medicines in China, homeopathic
EMA Headquarters to Move to Amsterdam

The European Council on Monday voted to move the European Medicines Agency’s (EMA) headquarters and nearly 900 staffers from London to Amsterdam – a move that’s expected to begin tomorrow and finish 30 March 2019.

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA Tags: EMA relocation, EMA move, EMA headquarters, Milan EMA
Regulatory Recon: Roche Surges on Positive Lung Cancer, Hemophilia A Results; Bayer Signs Development Deal with Japan's PeptiDream (20 November 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 Begins Adding Suffixes to Newly Approved Biologics' Names

The US Food and Drug Administration (FDA) this week began adding four-letter meaningless suffixes at the end of newly approved biologics' nonproprietary names, signaling a shift in its previous policy of only adding the suffixes to biosimilars.

Categories: Tags: nonproprietary name, FDA biologics naming, naming policy for medicines
FDA, EMA and PMDA Plot Harmonized Path for Antibiotics

Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA), met in Tokyo last month to plot out an approach that would allow drugmakers to conduct a single development plan for new antibiotics.

Categories: Drugs, Clinical, Preclinical, News, FDA, EMA, PMDA Tags: Antimicrobial Resistance, AMR, Antibiotics, Harmonization
House, Senate Pass Compromise Bill on FDA, DoD Emergency Use Authorizations

The Senate and House of Representatives this week passed a bill forging a compromise over a controversial provision in the National Defense Authorization Act for Fiscal Year 2018 (NDAA) that would have allowed the Department of Defense (DoD) to authorize the use of medical products on an emergency basis.

Categories: Crisis management, Regulatory strategy, Submission and registration, News, US, FDA Tags: NDAA, emergency use authorization
European Regulatory Roundup: EFPIA Warns of Insufficient Time to Move Marketing Authorizations Before Brexit (17 November 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, EU Regulatory Roundup
Regulatory Recon: FDA Panel Votes No on Bayer's Inhaled Cipro; Takeda CEO Eyes Deals Outside Japan (17 November 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
Devices Referencing Drugs: Questions Raised Over Potential Regulatory Pathways

The US Food and Drug Administration (FDA) on Thursday held a public hearing to look into the scientific, regulatory and legal challenges posed by devices referencing drugs (DRDs) and the agency's proposed approach to regulating such products.

Categories: Combination products, Drugs, Medical Devices, Postmarket surveillance, Submission and registration, News, US, FDA Tags: Devices Referencing Drugs, DRD, Combination Products
FDA Finalizes 2015 Draft Guidance on UDI Marking Requirements

The US Food and Drug Administration (FDA) on Thursday finalized guidance first released in 2015 to clarify when direct marking of devices with a unique device identifier (UDI) is required.

Categories: Medical Devices, News, US, FDA Tags: unique device identifiers
FDA Unveils New Regenerative Medicine Framework

The US Food and Drug Administration (FDA) on Thursday launched a new policy framework for regenerative medicine, building off a previous framework from 2005, as part of efforts to bring new cell, stem cell and tissue products to patients as efficiently as possible while managing the proliferation of unscrupulous actors hawking unproven therapies.

Categories: Biologics and biotechnology, Human cell and tissue, Medical Devices, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: regenerative medicine, RMAT, FDA guidance
Regulatory Recon: FDA Approves Roche Hemophilia A Drug Hemlibra; Ultragenyx Gets Priority Review Voucher With Enzyme Replacement Therapy Approval (16 November 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: House Passes GOP Tax Overhaul With Orphan Drug Tax Credit Repeal Included

The US House of Representatives on Thursday passed a bill to reform the US tax code by a vote of 227 to 205, with all Democrats voting against it and all but 13 Republicans voting for it.

Categories: Clinical, Research and development, Reimbursement, News, US, FDA Tags: orphan drug tax credit, tax reform
FDA Announces Third-Party Review Pathway for Tumor Profiling Tests

The US Food and Drug Administration (FDA) on Wednesday announced it has cleared a next-generation sequencing (NGS) test developed by Memorial Sloan Kettering Cancer Center (MSK) that can detect 468 unique gene mutations and other molecular biomarkers in a patient's tumor.

Categories: In vitro diagnostics, Submission and registration, News, US, FDA Tags: Next-Generation Sequencing, NGS, Tumor Profiling Tests, MSK-IMPACT, New York State Department of Health, NYSDOH
Lupin Warned by FDA for Deficiencies at Two Facilities

The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India.

Categories: Drugs, Manufacturing, News, US, India, FDA, APIs Tags: Warning Letter, GMP, Lupin, Goa, Indore
Drug Labels: Experts Note Importance of Faster Updates

The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research's annual meeting in Washington, D.C. on Wednesday.

Categories: Drugs, Government affairs, Labeling, News, US, FDA Tags: drug labels, cancer drug labels, Friends of Cancer Research
Regulatory Recon: AstraZeneca Bags Approvals for Fasenra, Faslodex; Shanghai Pharma to Buy Cardinal's China Business for $557M (15 November 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 Sets Monthly ANDA Records in October

The US Food and Drug Administration (FDA) in October issued complete responses to 325 abbreviated new drug applications (ANDAs) and approved or tentatively approved 101 ANDAs, the highest numbers in a single month since the enactment of Generic Drug User Fee Amendments (GDUFA).

Categories: Generic drugs, Submission and registration, News, US, FDA Tags: ANDAs, GDUFA II, Complete Responses
Experts Tell Senate Committee Current Gene Editing Regulations are Appropriate

At a Senate Health, Education, Labor and Pensions (HELP) hearing in Washington, D.C. on Tuesday, experts explained that the current regulatory framework for gene editing in the US is appropriate and cautioned that an overly strict approach could drive research to other countries.

Categories: Biologics and biotechnology, Clinical, Ethics, News, US, FDA Tags: Gene Editing, Gene Therapy, CRISPR, CRISPR-Cas9, Editas
FDA's Woodcock, Marks and Pazdur Talk Sustainability and New Approaches

Three of the US Food and Drug Administration's (FDA) top experts sat together on a panel at the third Biopharma Congress in Washington, D.C. on Tuesday, discussing everything from where the agency is headed in the next several years, how the costly clinical trial system is not sustainable and how they interview prospective FDA employees.

Categories: Biologics and biotechnology, Drugs, News, US, CBER, CDER Tags: Pazdur, Marks, Woodcock, oncology center of excellence
Regulatory Recon: FDA Approves Otsuka, Proteus' Digital Pill; Janssen Drops Suit Against Samsung Bioepis' Remicade Biosimilar (14 November 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
Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements (14 November 2017)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Quality, Submission and registration, News, Asia, Oceania, CDSCO, TGA Tags: Asia Regulatory Roundup, Regulatory Roundup
Why Don't EMA and FDA Speak With the Same Voice on Flu Treatments? Researchers Investigate

New research published last week digs into cross-national regulatory divergences, with a focus on why some US labels for certain flu treatments say the medicines have not been proven to reduce complications while EU labels claim the opposite.

Categories: Drugs, Clinical, Government affairs, News, US, Europe, FDA, EMA Tags: Relenza, Tamiflu, regulatory divergence
EMA, EUnetHTA Sign Off on Three-Year Work Plan

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) on Monday detailed their priorities for the next three years in a joint work plan.

Categories: Biologics and biotechnology, Drugs, Reimbursement, Submission and registration, News, Europe, EMA Tags: EUnetHTA, HTA, Health Technology Assessment, Parallel Advice
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