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.

CA Congressman Seeks More FDA Outreach for Biotech Start-Ups

Rep. Eric Swalwell (D-CA) on Friday sent a letter to US Food and Drug Administration (FDA) Commissioner Robert Califf seeking further assistance for start-up biotechnology companies in the Bay Area.

Categories: Biologics and biotechnology, News, US, FDA Tags: FDA in San Francisco, biotech start-ups
FDA’s CDER Lays Out Rules for Public-Private Partnerships

The US Food and Drug Administration (FDA) on Friday published a manual of policies and procedures (MAPP) describing how staff from the Center for Drug Evaluation and Research (CDER) can engage in public-private partnerships and consortia to facilitate, inform, and help the external groups understand CDER’s current thinking in a role separate from any regulatory review process.

Categories: News, US, CDER Tags: CDER partnerships, public-private partnerships, FDA and non-profits
EMA Revises Clinical Data Publication Guidance, Updates on Program

The European Medicines Agency (EMA) on Friday released a revised version of its guidance on complying with its new policy on the publication of clinical data that went into effect in October.

Categories: Biologics and biotechnology, Drugs, Clinical, Submission and registration, News, Europe, EMA Tags: Clinical trial transparency, Clinical study reports
Medical Device Performance Goals: FDA Offers a Quarterly Update

The US Food and Drug Administration (FDA) on Friday released its latest performance data, revealing that the number of premarket applications (PMAs) for devices with a major deficiency letter on the first FDA review cycle is up to its highest level ever, and up more than 25% since 2015.

Categories: Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH Tags: 510(k), PMA, FDA approval of medical device, devices substantially equivalent
Regulatory Recon: AstraZeneca, Endo to Cut Hundreds of US Jobs; More Promising Data From Biogen Alzheimer's Study (9 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
Former Insys Executives Arrested on Racketeering Charges

Six former Insys Therapeutics executives and managers were arrested on Thursday on charges that they conspired to bribe healthcare practitioners to prescribe the company's fast-acting fentanyl spray Subsys.

Categories: Drugs, News, US, DOJ Tags: Insys, Department of Justice, Kickbacks, Subsys, Opioid Epidemic
FDA Finalizes Drug Supply Chain Guidance, Seeks Comment on New Section

The US Food and Drug Administration (FDA) on Thursday released final guidance on the implementation of the Drug Supply Chain Security Act (DSCSA), though it’s also seeking comment on a new section describing when manufacturers should notify FDA of a high risk that a product is illegitimate.

Categories: Biologics and biotechnology, Drugs, Crisis management, Government affairs, Postmarket surveillance, Regulatory strategy, Regulatory intelligence, News, US, FDA, Business and Leadership Tags: DSCSA, track and trace, supply chain pharmaceuticals, FDA guidance
European Regulatory Roundup: UK Fines Pfizer for 2,600% Price Hike (8 December 2016)

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

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, Europe, EMA, EC, MHRA Tags: European Regulatory Roundup, Pfizer, ATMP, GMP manufacturing, antimicrobial resistance
US Solicitor General Calls on Supreme Court to Review Six-Month Delays to Biosimilar Launches

With the timing of all future US launches of biosimilars at stake, the US Solicitor General has called on the Supreme Court to review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products.

Categories: Biologics and biotechnology, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: biosimilars, US Supreme Court, Federal Circuit, biosimilar launch
FDA Says Real-World Evidence Could Generate 'Incorrect or Unreliable Conclusions’

Fifteen top US Food and Drug Administration (FDA) officials published an article in the New England Journal of Medicine on Thursday calling into question some of the potential uses of real-world evidence (RWE) but also acknowledging that real world research and the concepts of a planned intervention and randomization “are entirely compatible."

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: 21st Century Cures, real-world evidence, real-world data and pharmaceuticals
Regulatory Recon: Two Possible Trump Picks for FDA Commissioner; Will Congress Ax Recent FDA Rules in the Next Administration? (8 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
FDA Makes Hearing Aids More Accessible

In a move intended to improve patient access to hearing aids, the US Food and Drug Administration (FDA) on Wednesday issued an immediately effective guidance that reduces the regulatory requirements for selling certain hearing aids.

Categories: Medical Devices, News, US, FDA Tags: Hearing Aids
Cassidy Says Obamacare Repeal Will Not Repeal Biosimilars Approval Pathway

Sen. Bill Cassidy (R-LA) told attendees of a policy briefing at the Newseum on Wednesday that when Republicans repeal Obamacare, which is expected to occur soon after President-elect Donald Trump takes office, the approval pathway for biosimilars that was created thanks to that law will not go away.

Categories: Biologics and biotechnology, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA, Business and Leadership Tags: Obamacare, ACA, biosimilars, Bill Cassidy
Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: Cures, 21st Century Cures, regenerative medicine, FDA, safety and efficacy
Regulatory Recon: Pfizer Hit With Record £84M Fine for Overcharging NHS; Mylan Eyes 3,500 Layoffs in Cost Cutting Drive (7 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
Ethical Guidelines for Human Research Revised

The Council for International Organizations of Medical Sciences (CIOMS) last week finalized the latest revision to its ethical guidelines for health research involving human participants.

Categories: Clinical, Ethics, News Tags: Council for International Organizations of Medical Sciences, CIOMS, Medical Ethics
FDA Warns Spanish API Maker for GMP Violations

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Spanish active pharmaceutical ingredient (API) maker Interquim, S.A. for several good manufacturing practices (GMP) violations uncovered during an inspection of the company's Barcelona facility last May.

Categories: Active pharmaceutical ingredients, Manufacturing, News, US, Europe, FDA, APIs Tags: Warning Letter, Good Manufacturing Practice, GMP
Leahy Looks to Amend ‘Cures’ Bill as Senate Prepares for Passage

Sen. Patrick Leahy (D-VT) on Tuesday proposed an amendment to the 21st Century Cures bill that would make it more difficult for brand name drugmakers to halt or delay generic or biosimilar competition.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Manufacturing, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: 21st Century Cures, GPhA, Leahy, generic drugs, NIH
Regulatory Recon: Report Says Global Drug Spending to Hit $1.5 Trillion in 2021; Sanofi Weighing Counterbid for Actelion (6 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
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
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