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.

Patient-Focused Drug Development Tracker

The US Food and Drug Administration's patient-focused drug development program is poised to overhaul how drugs are approved for rare and inadequately served diseases and conditions. This tracker provides an in-depth look at what questions FDA is asking of patients and their representatives.

Categories: Biologics and biotechnology, Drugs, Orphan products, News, US, CBER, CDER Tags: Patients, Patient-Focused Drug Development, FDASIA, View of Patients, PFDD
FDA Legislation Tracker

Regulatory Focus is pleased to offer this webpage as a way to keep track of legislation—both passed and proposed—intending to affect areas regulated by FDA. We intend to update this webpage regularly, so please check back often.

Categories: Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices, Regulatory intelligence, News, US, FDA Tags: FDA Legislation Tracker, Legislation, Bill, House, Congress, President, FDA Legislation, FDA Bill
FDA Cancels Study of How it Can Use Drones to Conduct Inspections

The US Food and Drug Administration (FDA) is no longer considering the use of aerial drones to help assist its on-site inspections of facilities, less than 24 hours after initially saying feasibility studies were in the works.

Categories: Audit, Manufacturing Tags: Drone, Drone Testing, Aerial Drone, Unmanned Aerial Drone, Inspections
Regulatory Recon: One Last News Roundup Before we Go on Holiday (19 December 2014)

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
Obama Signs Special Ebola Incentive Program Into Law

President Barack Obama has signed a new bill into law allowing any pharmaceutical or biotechnology company that successfully develops a product to treat the Ebola virus to obtain a special voucher potentially worth millions—and even billions—of dollars.

Categories: Biologics and biotechnology, Drugs, Submission and registration, News, US, CDER Tags: Ebola, Priority Review Voucher, PRV, Neglected Tropical Disease Priority Review Voucher, Bill, Legislation, Congress, President Barack Obama, Adding Ebola to the FDA Priority Review Voucher Program Act
FDA Studying How it Can Use Drones to Conduct Inspections (Updated)

The US Food and Drug Administration (FDA) is considering the use of aerial drones to help assist its on-site inspections of facilities, the agency confirmed to Regulatory Focus this week.

Categories: Audit, Manufacturing, News, US, FDA Tags: Drone, Drone Technology, Aerial Drones, Inspections
Regulatory Recon: Third Biosimilar Application Sent to FDA (18 December 2014)

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: EMA Says Ebola Treatments Need More Study (17 December 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News
FDA Proposal Calls for Drug Labeling to be Distributed to Doctors Electronically

In a long-anticipated and major move, the US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically.

Categories: Biologics and biotechnology, Drugs, Labeling, News, US, CDER, Advertising and Promotion Tags: Drug Labeling, Proposed Rule, Rule, Regulation, Proposed Regulation, Professional Labeling, Prescribing Information
FDA Appoints Members to New, Influential Advisory Committee

Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector.

Categories: Drugs, News, US, CDER Tags: PCAC, Pharmacy Compounding Advisory Committee, Difficult-to-Compound List, AdComm, Advisory Committee
Regulatory Recon: Novartis Acromegaly Drug Approved by FDA (16 December 2014)

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
Anabolic Steroid Regulation Bill Awaits President's Signature

New legislation set to be signed into law by US President Barack Obama would ban dozens of active ingredients now used in the production of anabolic steroids, and also make it easier for federal authorities to prohibit the production of similar products.

Categories: Drugs, Nutritional and dietary supplements, Labeling, Submission and registration, News, US Tags: Legislation, Bill, Congress, Anabolic Steroid, Designer Anabolic Steroid Control Act, (DASCA), DEA
Supreme Court Declines to Hear Case on Off-Label Prescribing Authority

The US Supreme Court has refused to hear a challenge to an Arizona law that sought to limit the use of an abortion drug, avoiding a potential showdown over whether off-label prescribing is explicitly allowed under federal law, or simply tolerated.

Categories: Drugs, Labeling, News, US, FDA Tags: Supreme Court, SCOTUS, Planned Parenthood v. Humble, Court Case, Off-Label Prescribing
Regulatory Recon: Bayer Loses Major Battle Over Cancer Drug (15 December 2014)

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
How Should Diagnostic Tests be Regulated? Congress Wants to Know

A new white paper published by the House Energy and Commerce Committee is calling for feedback on the US Food and Drug Administration's (FDA) proposal to regulate laboratory developed tests (LDTs) more similarly to how they regulate in vitro diagnostics.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, US, CDRH Tags: LDT, Lab Developed Tests, Laboratory Developed Tests, Congress, Energy and Commerce Committee, E&C, Whitepaper, White Paper
Will an MRI Damage my Implant? New FDA Policy Aims to Improve Safety

Can a medical device be used safely around magnetic resonance imaging equipment? It's not always easy for healthcare providers or patients to know. Now a new final guidance document issued by the US Food and Drug Administration (FDA) recommends that medical device manufacturers test and label their products to ensure that use of their devices doesn't lead to injuries.

Categories: Medical Devices, Labeling, News, US, CDRH Tags: MRI, Magnetic Resonance, Magnetic Resonance Imaging, Guidance, Final Guidance
FDA Advisory Committee Calendar

Regulatory Focus is pleased to team with Tarius, a regulatory information services provider, to routinely offer insight about upcoming FDA Scientific Advisory Committee (SAC) meetings for CDER, CBER, and the Office of the Commissioner.

Categories: Biologics and biotechnology, Prescription drugs, Generic drugs, Over the counter drugs, Postmarket surveillance, News, US, CBER, CDER Tags: AdComm, FDA Advisory Committee, FDA Advisory Committee Calendar, FDA Advisory Committee Meetings, FDA Scientific Advisory Committees
Senators Call for 15 Years of Marketing Exclusivity for Some New Drugs

Two US senators have proposed new legislation that would grant an unprecedented 15 years of marketing exclusivity to certain types of pharmaceutical and biopharmaceutical products.

Categories: Biologics and biotechnology, Drugs, News, US, CDER Tags: MODDERN Cures Act, Marketing Exclusivity, Senate, Congress, Bill, Legislation, Dormant Therapies Act
Regulatory Recon: FDA Creates New Working Group on Compassionate Use (12 December 2014)

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
Indian Regulator Soliciting Feedback on Regulatory System Upgrade Plan

India’s Central Drugs Standards Control Organisation (CDSCO) is soliciting feedback on the Ministry of Health and Welfare's plan to upgrade the country’s regulatory system at both national and state levels over the next three years.

Categories: Drugs, News, India, CDSCO Tags: RegLink, Regulatory Capacity
European Regulatory Roundup: The EU's Drug Data Scandal (11 December 2014)

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

Categories: Regulatory intelligence, News, Europe, EMA, EC, MHRA Tags: EU Regulatory Roundup, Regulatory Roundup, European Regulatory Roundup
FDA Touts Strong Drug Approval Performance in 2014

The US Food and Drug Administration (FDA) is touting the number of new molecular entities it has approved thus far in 2014, saying the numbers are indicative of a "strong year for novel drug approvals."

Categories: Biologics and biotechnology, Drugs, News, US, CDER Tags: FDA New Drug Approvals, 2014 New Drug Approvals, FDA NME Approvals
Pharmaceutical Companies Look to Create Better Compassionate Use Process

The prominent US pharmaceutical trade group PhRMA has released an updated set of principles it says reflects the US pharmaceutical industry's "commitment" to provide patients with life-threatening diseases access to investigational therapies on a compassionate-use basis.

Categories: Biologics and biotechnology, Drugs, Clinical, Ethics, News, US Tags: Compassionate Use, Expanded Access, PhRMA, PhRMA Expanded Access Principles
Bill Seeks Creation of New Pathway for Antibiotic Drug Approvals

New legislation would allow the US Food and Drug Administration (FDA) to approve some antibiotics through a special "limited use" regulatory pathway, all in the hope of bringing more antibiotics to market to help fight antibiotic-resistant bacteria.

Categories: Prescription drugs, Clinical, Submission and registration, News, US, FDA Tags: Antibiotics, Legislation, Bill, Limited Population Pathway, Promise for Antibiotics and Therapeutics for Health (PATH) Act, Congress, Senate
FDA Proposes Changes to its Adverse Event Reporting Forms

The US Food and Drug Administration (FDA) is proposing several changes to its adverse event reporting forms, known within the industry as Forms 3500, 3500A and 3500B.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Nutritional and dietary supplements, Postmarket surveillance, News, US, FDA Tags: MedWatch, Form 3500, Form 3500A, Form 3500B
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