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.

Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Manufacturing, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA, Medsafe, ANZTPA Tags: GMP pharmaceutical manufacturing, Chinese drug inspections, DTAB, Sugam, Asia Regulatory Roundup
Vermont Drug Price Transparency: New Law Calls Out Egregious Price Spikes

Last June, Vermont Governor Peter Shumlin (D) signed into law a new pharmaceutical price transparency bill that sought to expose the companies and products seeing the largest price hikes.

Categories: Biologics and biotechnology, Drugs, Reimbursement, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, Business and Leadership Tags: pharmaceutical price transparency, drug prices, increases in drug prices, Vermont pharmaceuticals, Medicaid
WHO Prequalifies First Hepatitis C Diagnostic

The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment.

Categories: In vitro diagnostics, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, Europe, Asia, Latin America and Caribbean, Africa, Middle East, WHO Tags: WHO, prequalification, Gilead, Hepatitis C
FDA Classifies Post-Concussion Test

Months after clearing the first computer-based test intended to measure cognitive function after a suspected concussion, the US Food and Drug Administration (FDA) on Monday said it considers such devices to be Class II, or moderate risk devices.

Categories: Medical Devices, Labeling, Submission and registration, News, US, FDA Tags: ImPACT, Concussion, Post-Concusion, Class II, De Novo
FDA’s Office of New Drugs Director to Retire

After nearly 25 years of service at the US Food and Drug Administration (FDA), John Jenkins, MD, Director of the Office of New Drugs (OND), will retire from the federal government on 6 January 2017.

Categories: Biologics and biotechnology, Drugs, Orphan products, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, CDER Tags: John Jenkins, Office of New Drugs, OND, CDER's OND, new drug applications
Regulatory Recon: Senate to Begin Cures Debate Tonight; FDA Close to Finishing Combination Product Reporting Rule (5 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed Friday's Recon? Read it here.

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 Finalizes Guidance on Labeling

The US Food and Drug Administration (FDA) on Friday finalized its guidance for completing the clinical pharmacology section for drug, generic drug and biologic labels.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Labeling, News, US, FDA Tags: Clinical pharmacology
ICH Advances Three Guidance Documents

The International Council for Harmonisation (ICH) earlier this week advanced two guidelines to Step 4, or the implementation period of its process, and one question and answer document on the development and manufacture of drug substances to Step 2b of its process, meaning it enters a consultation phase.

Categories: Drugs, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, Canada, Europe, Asia, Africa, FDA, ICH Tags: Q11, Q3C(R6), E6(R1), ICH guidelines, drug manufacturing
Regulatory Recon: J&J Hit With $1Bn Verdict in Hip Implant Trial; TPP Exit Forces Look at Global Biopharma IP Challenges (2 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
Why Don’t People Like Pharma Companies? Pfizer and Regeneron CEOs Discuss

At the end of Thursday's Forbes healthcare summit in New York, some of the pharmaceutical and biotech industries’ top executives – from Pfizer, Regeneron, Eli Lilly, Gilead and Astellas – sat down and were presented with a simple question: Why don’t people like you?

Categories: News Tags: Regeneron, Eli Lilly, Pfizer, Astellas, Gilead, Forbes
Top FDA Officials Defend Agency Stance on Stem Cell Therapies

Officials from the US Food and Drug Administration (FDA) are defending its proposed approach to regulating stem cell therapies in response to criticism that doing so would slow access to such treatments.

Categories: Human cell and tissue, News, US, FDA Tags: Stem cells
FDA Issues Draft Guidance on Physiologically Based Pharmacokinetic Analyses

The US Food and Drug Administration (FDA) on Thursday released a new draft guidance intended to help sponsors report physiologically based pharmacokinetic (PBPK) analyses to the agency in a standardized format.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Preclinical, Submission and registration, News, US, FDA Tags: Physiology based pharmacokinetics analyses, PBPK
Mylan CEO Defends EpiPen Price Increases

Mylan CEO Heather Bresch on Thursday defended the more than 400% price increase for its life-saving EpiPen, saying the company has made the device “more ergonomic” and that patients “never see the needle.”

Categories: Generic drugs, Government affairs, Reimbursement, Regulatory strategy, Regulatory intelligence, News, US, Business and Leadership Tags: EpiPen, Mylan, Heather Bresch, generic drug price gouging
Regulatory Recon: Bluebird Reports Promising Results From Small CAR-T Study;Top US Heart Docs Want Califf to Continue as FDA Commissioner (1 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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: EMA Releases Draft Guidance on Using Pictograms on Packaging (1 December 2016)

The European Medicines Agency (EMA) has posted draft guidance on the use of approved pictograms on veterinary medicinal product packaging. EMA has drafted the document to create a harmonized set of pictograms marketing authorization holders (MAHs) can use to communicate effectively in the limited space available on product packaging.

Categories: Biologics and biotechnology, Drugs, Labeling, Packaging, News, Europe, EMA, EC, MHRA Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
Final FDA Rule Reworks Import Data Submissions

The US Food and Drug Administration (FDA) on Tuesday issued a final rule requiring companies to submit data for FDA-regulated products via a new electronic system intended to serve as a "single access point" for imported products.

Categories: Biologics and biotechnology, Drugs, Human cell and tissue, Medical Devices, News, US, FDA Tags: ACE, Automated Commercial Environment
House to Pass Revamped 21st Century Cures Bill

The US House of Representatives on Wednesday is poised to pass a wide-ranging bill that will overhaul certain aspects of the US Food and Drug Administration (FDA) and provide the agency with more funding.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: 21st Century Cures, #CuresNow, Cancer Moonshot, FDA legislation, lame duck session
FDA Warns Specialty Pharma Company Over Adverse Event Reporting

The US Food and Drug Administration (FDA) sent a warning letter to Langhorne, Pennsylvania-based STI Pharma LLC for failing to meet the agency's requirements for adverse event reporting.

Categories: Drugs, Postmarket surveillance, News, US, FDA Tags: STI Pharma LLC, Postmarketing Adverse Drug Experience, PADE
Regulatory Recon: Pfizer Herceptin Biosimilar Succeeds in Key Study; Pharma Companies Argue Against New UK Regulator (30 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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 Finalizes Guidance on Providing Postmarket Safety Reports in ICH Format

The US Food and Drug Administration (FDA) on Tuesday finalized guidance describing the conditions under which companies can use an alternative reporting format to satisfy postmarketing safety reporting requirements.

Categories: Biologics and biotechnology, Drugs, Due Diligence, Research and development, Quality, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, FDA, ICH Tags: ICH guidance, PSUR, PAER, PADER, PBRER
How to Mitigate Cross-Contamination During Colonoscopies, Final FDA Guidance Explains

During a colonoscopy or esophagogastroduodenoscopy (EGD), clinicians often use an irrigation system but typically do not clean and sterilize all components of the system after each procedure, so the US Food and Drug Administration (FDA) on Tuesday issued guidance highlighting the risks of cross-contamination posed by specific practices and types of irrigation valves and accessories.

Categories: Medical Devices, Crisis management, Compliance, Government affairs, News, US, CDRH Tags: colonoscopy, cross-contamination of medical devices, medical device safety, device irrigation systems
EMA Highlights Central Nervous System Drug Development Challenges

The European Medicines Agency (EMA) on Tuesday published an analysis highlighting the complexity of developing treatments for central nervous system (CNS) disorders, such as Alzheimer's disease, epilepsy and schizophrenia.

Categories: Drugs, Clinical, Preclinical, Submission and registration, News, Europe, EMA Tags: Central nervous system disorders, CNS
Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, Asia, CFDA, CDSCO, TGA Tags: drug recalls, medicinal cannabis, antidiabetic
FDA Warns Chinese Heparin Manufacturer, Reigniting Questions of Contamination

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent earlier this month to a China-based manufacturer of heparin—the same manufacturer warned by French regulators last March.

Categories: Active pharmaceutical ingredients, Government affairs, Manufacturing, Quality, Regulatory strategy, Regulatory intelligence, News, US, Asia, FDA Tags: heparin, warning letter, heparin manufacturers in China
Regulatory Recon: Trump Picks Tom Price as HHS Secretary; Apple Emails Hint at Plans for FDA-Regulated Devices (29 November 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

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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