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.

Regulatory Recon: Merck's Keytruda Combo Extends Survival in Lung Cancer Trial; Sandoz Files Humira Biosimilar for US Approval (16 January 2018)

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
Transparency: FDA to Release Portions of Redacted Clinical Study Reports

As part of a push to be more transparent about its decision making, the US Food and Drug Administration (FDA) on Tuesday announced it will launch a pilot project to publicly release portions of clinical trial-related summaries from the pivotal trials that were submitted to the FDA by the drug’s sponsor.

Categories: Drugs, Clinical, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: FDA transparency, Johns Hopkins, Gottlieb
Markey and Warren Re-Intro Bill to Repeal Medical Device Tax

Sens. Ed Markey (D-MA) and Elizabeth Warren (D-MA) re-introduced a bill from 2015 last week that would permanently repeal a 2.3% medical device tax that was delayed for two years but took effect at the beginning of this year.

Categories: Medical Devices, Government affairs, News, US Tags: Elizabeth Warren, medical device tax
FDA Looks Ahead and Back on Orally Inhaled and Nasal Generic Drugs

The US Food and Drug Administration (FDA) has come a long way when it comes to locally acting orally inhaled and nasal drug products (OINDPs) and in the next five years of generic drug user fees, the agency is looking at further progress on some unique challenges, according to a regulatory science report on OINDPs.

Categories: Generic drugs, Research and development, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: OINDP, locally acting orally inhaled and nasal drug products
FDA Details New Manufacturing Quality Pilot Program

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) last month released details on its upcoming voluntary medical device manufacturing and product quality pilot program as part of its Case for Quality (CfQ) initiative.

Categories: Medical Devices, Manufacturing, Quality, News, US, FDA Tags: Case for Quality, Pilot
Regulatory Recon: Google Backs UK Universal Vaccine Company; Shire Wins EU Approval for Long Acting Hemophilia A Treatment (15 January 2018)

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 Delays Implementing Parts of 'Intended Use' Rule

Confusion and concerns over portions of a tobacco-related final rule that could have major ramifications for the medical product industries has pushed the US Food and Drug Administration (FDA) to delay the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used.

Categories: Biologics and biotechnology, Drugs, Medical Devices, News, US, FDA Tags: intended use, First Amendment, FDA rule
FTC Settles Complaint Over Deceptive Marketing of Unapproved Cancer Products

The US Federal Trade Commission (FTC) on Thursday announced it has reached a settlement with CellMark Biopharma related to the company's claims about marketing efforts to sell two of its unapproved products.

Categories: News, US, FDA, FTC, Advertising and Promotion Tags: FTC, Federal Trade Commission, CellMark
FDA Warns BD Over Changes Made to Blood Collection Tubes in Lead Testing Investigation

After launching an investigation into the root cause of false lead test results from four of Magellan Diagnostics' LeadCare testing systems last May, the US Food and Drug Administration (FDA) on Thursday warned Becton Dickinson (BD) for failing to submit a new 510(k) for changes to its blood collection tubes.

Categories: In vitro diagnostics, Medical Devices, News, FDA Tags: BD, LeadCare, Magellan Diagnostics, Vacutainer, Warning Letter
FDA Pushes Back Enforcement of UDI Requirements for Class I, Unclassified Devices

The US Food and Drug Administration (FDA) said Friday that it will delay its enforcement of certain unique device identification (UDI) system requirements for class I and unclassified devices by two years.

Categories: Medical Devices, Compliance, Due Diligence, Government affairs, News, US, CDRH Tags: unique device identification, Class I, unclassified devices, UDI enforcement
Regulatory Recon: FDA Approves AZ's Lynparza to Treat Breast Cancer with BRCA Mutation; Roche's MS Drug Ocrevus Wins EU Approval (12 January 2018)

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 Warns Doctors of Collapsed Lungs and Deaths Possibly Linked to Feeding Tube Placement Devices

The US Food and Drug Administration (FDA) on Thursday sent a letter to health care providers to provide information about reports of pneumothorax events, or collapsed lungs, and deaths associated with feeding tube placement procedures using some enteral access systems (EAS).

Categories: Medical Devices, Crisis management, Due Diligence, Government affairs, News, US, FDA Tags: feeding tubes, EAS, collapsed lung
Bioethicists Say Federal Right-to-Try Legislation Will Have Limited Impact on Access

In a perspective published in the New England Journal of Medicine on Wednesday, bioethicists Holly Fernandez Lynch and Steven Joffe of the University of Pennsylvania warn that federal "right-to-try" legislation could undermine the US Food and Drug Administration's (FDA) public health mission and will have a limited impact on improving patient access to investigational products.

Categories: Biologics and biotechnology, Drugs, Clinical, Ethics, News, US, FDA Tags: Right-to-Try, Expanded Access
ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: Biologics and biotechnology, Drugs, Crisis management, Government affairs, Quality, Regulatory intelligence, News, US, Europe, Asia, FDA, EMA, MHRA Tags: ICMRA, track and trace, interoperability
FDA Requires Labeling Changes for Some Cough and Cold Drugs to Better Protect Children

The US Food and Drug Administration (FDA) on Thursday announced safety labeling changes for prescription cough and cold medicines containing codeine or hydrocodone as the risks of these medicines outweigh their benefits in children younger than 18.

Categories: Drugs, Crisis management, Compliance, Labeling, News, US, FDA Tags: codeine, cough and cold, hydrocodone
FDA Plots Policy Priorities for 2018

The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: generic competition, total product lifecycle, opioids
European Regulatory Roundup: Swissmedic Updates Biosimilar Guidance (11 January 2018)

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 Tags: European Regulatory Roundup, Swissmedic, biosimilars, multi-dose containers
Regulatory Recon: FDA Panel Votes Against Testosterone Therapies; Endo Subpoenaed for Opioid Information (11 January 2018)

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
Device Recalls in 2017: Making Sense of the Numbers

Each year, the US Food and Drug Administration (FDA) designates anywhere from dozen to hundreds of medical device recalls as Class I, indicating that the risk addressed by the recall could potentially cause serious injury or death.

Categories: In vitro diagnostics, Medical Devices, News, US, FDA Tags: Recalls, Corrections, Removals, Class I Recall
House E&C Offers Recommendations to Improve 340B Drug Pricing Program

The House Energy & Commerce (E&C) Committee on Wednesday released an 80-page report outlining issues related to the 340B drug pricing program, which helps reduce the prices of certain drugs for participating hospitals, health centers and other entities that provide care for vulnerable patients, and recommendations to improve the program’s administration.

Categories: Drugs, Government affairs, Reimbursement, News, US Tags: HRSA, 340B, drug discount, House Energy & Commerce
EMA Adopts Guideline on Clinical Trials for Rheumatoid Arthritis Treatments

The European Medicines Agency (EMA) on Wednesday announced the adoption of a guideline, first drafted in 2011, on the clinical evaluation of medicinal products in the treatment of the autoimmune disease rheumatoid arthritis (RA).

Categories: Biologics and biotechnology, Drugs, Clinical, Regulatory strategy, Regulatory intelligence, News, Europe, EMA Tags: rheumatoid arthritis, EMA guideline
CDER Report on Novel Approvals Highlights Firsts in 2017

2017 was a year of firsts for the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), with initial approvals in at least five medical conditions and other firsts that might not end up on the final scorecard, like the first biosimilar cancer treatment or the first immediate-release opioid with abuse-deterrent properties.

Categories: Biologics and biotechnology, Drugs, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA Tags: 2017 novel drug approvals, CDER report, Woodcock, Gottlieb
Regulatory Recon: Bluebird Planning for First Three Approvals by 2019; EU Approves Vertex' Orkambi for Younger Patients (10 January 2018)

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
New Study Looks at FDA's Use of Social Media to Communicate on Drug Safety

A new study looking at the US Food and Drug Administration's (FDA) use of social media to communicate about drug safety finds that the agency could improve its impact by developing social media strategies and taking a more active role on web platforms.

Categories: Drugs, News, US, FDA, Communication Tags: Twitter, Facebook, Social Media, Safety Communications
Barriers to FDA and CMS Parallel Reviews: Fear and Bandwidth, Shuren Says

Medical device companies should want to streamline the process of getting their products reviewed simultaneously by the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) and Centers for Medicare and Medicaid Services (CMS) - so why aren’t they?

Categories: In vitro diagnostics, Medical Devices, Preclinical, Regulatory strategy, Regulatory intelligence, News, US, CDRH Tags: parallel review, Shuren, MOU
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