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.

FDA Scientific Advisory Committee Meeting Tracker

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
Regulatory Recon: Why Did Amazon Meet With FDA? (22 August 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
Australia’s TGA Opens Review of All Surgical Mesh Devices

Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for all urogynecological surgical mesh implants to determine if they comply with the requirements for safety and performance necessary for marketing approval. 

Categories: Medical Devices, Postmarket surveillance, News, Oceania, TGA Tags: Vaginal Mesh, Urogynecological Surgical Mesh
Pfizer Launches Expanded Access Program for Breast Cancer Drug

The US Food and Drug Administration's (FDA) expanded access program, sometimes referred to as its "Compassionate Use" program, has frequently been in the news as of late, as dozens of patients have taken to social media in an attempt to pressure companies into allowing them access to clinical trials they believe might save their lives. But while many companies have seemed reluctant to grant access to those trials, pharmaceutical giant Pfizer is taking a markedly different approach for a new expanded access trial for its breast cancer drug palbociclib.

Categories: Prescription drugs, Clinical, News, US Tags: Pfizer, EAP, Expanded Access Program, Expanded Access, Breast Cancer, Compassionate Use, Palbociclib
Australian TGA Taking a More Discerning Approach to Notified Bodies

The Australian Therapeutic Goods Administration (TGA) plans to conduct application audits for medical devices seeking entry into the Australian Register of Therapeutic Goods (ARTG) using conformity assessments from several Notified Bodies. The TGA move could cause delayed Australian market entry for manufacturers that have used these Notified Bodies for certification.

Categories: Medical Devices, Audit, Submission and registration, News, Oceania, TGA Tags: Notified Body, BMJ, British Medical Journal, Conformity Assessment, Australia
FDA Releases PhRMA Proposal on How Drug Names Could be Reserved Prior to Launch

US regulators have finally released the text of a 2009 industry proposal that is set to form the basis of discussion at an upcoming meeting on whether companies should be allowed to "reserve" drug names for late-stage investigational drugs.

Categories: Biologics and biotechnology, Drugs, Labeling, News, US, CDER Tags: PhRMA, Draft Guidance, Drug Naming, Drug Name, Drug Name Reservation
FDA Unveils Policies Meant to Boost Safety, Efficacy of Medical Products for Women, Minorities

The US Food and Drug Administration (FDA) has released new recommendations on the inclusion of women and other minorities in clinical trials, citing the need to better represent populations which have historically not been adequately included in clinical research.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Clinical, Labeling, News, US, FDA Tags: Section 907 Report, FDASIA, Section 907, Final Guidance, Guidance, Sex, Age, Race, Minorities, Female, Women, Ethnicity
DEA, Following FDA Recommendation, to Toughen Regulation on Popular Class of Painkillers

In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law.

Categories: Prescription drugs, Generic drugs, Distribution, Postmarket surveillance, News, US Tags: DEA, Hydrocodone, Schedule II, Schedule III, Final Rule, Rescheduling, Hydrocodone Combination Products
Regulatory Recon: FDA Confirms Role in Facilitating Ebola Drug Access (21 August 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
FDA Device Approvals Speedy in First Half of 2014, With Even Faster Approvals Coming Soon

The US Food and Drug Administration (FDA) approved new medical device products at a pace nearly twice that of the year prior, according to a new report just published by analysts at EP Vantage, a market intelligence firm.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, US, CDRH Tags: PMA, HDE, Medical Device Approvals, CDRH Approvals
New Updates to FDA's Website Make it Easier to Track Device Recalls, Drug Changes

US regulators have announced the release of a treasure trove of data regarding medical device recalls and drug labeling, the latest releases under the US Food and Drug Administration's (FDA) new openFDA program.

Categories: Biologics and biotechnology, Drugs, Medical Devices, Labeling, News, US, FDA Tags: openFDA, MAUDE, SPL, Drug Labels, MDR, Medical Device Adverse Event, AE
Brazilian Regulator Anvisa Issues New Track and Trace Guidance

Brazil’s national regulatory agency, Anvisa, has published guidance on the implementation of the country's track and trace system for drugs, the National Drug Control System (SNCM). 

Categories: Biologics and biotechnology, Drugs, News, Latin America and Caribbean, Anvisa Tags: Track and Trace, SNCM, National Drug Control System
FDA Extends UDI Compliance Date for Most Contact Lenses

Some medical device manufacturers will have an additional year to comply with the US Food and Drug Administration's (FDA) Unique Device Identification (UDI) rule, a 2013 regulation intended to allow regulators to exercise greater oversight of the device industry.

Categories: Medical Devices, Compliance, Labeling, Packaging, News, US, CDRH Tags: UDI, Unique Device Identification, 21 CFR 801.55(d), Direct Marking, GUDID, IOLs, Contact Lenses
Regulatory Recon: FDA Approves Gaucher Drug, Clears 3D-Printed Skull (20 August 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
One of FDA's Top Device Regulators Stepping Aside

One of the US Food and Drug Administration's (FDA) top medical device regulators, Christy Foreman, will soon be giving up her position to focus on tobacco regulation at the agency.

Categories: Medical Devices, Submission and registration, News, US, CDRH Tags: Christy Foreman, 510(k), Mobile App Regulation, Leaving, ODE
Are New Policies Needed to Help Regulate Generic Drugs? FDA Wants to Know

US drug regulators are getting ready to take a close look at the regulation of generic drugs, including new policies recently proposed by the US Food and Drug Administration (FDA) and areas that could stand to benefit from additional regulation.

Categories: Generic drugs, Submission and registration, News, US, CDER Tags: Guidance, Draft Guidance, Meeting, 180-Day Exclusivity
FDA Guidance Shelves Plan Intended to Help Accelerate Clinical Research on Medical Devices

A new final guidance document issued by the US Food and Drug Administration (FDA) is intended to "promote" clinical studies of new medical devices under the agency's Investigational Device Exemption (IDE) regulations, but no longer includes a program proposed by FDA in 2013 meant to accelerate the clinical assessment process.

Categories: Medical Devices, Clinical, Submission and registration, News, US, CDRH Tags: IDE, Investigational Device Exemption, Guidance Document, Guidance, Final Guidance
India's Data Integrity Problems (Updated 19 August 2014)

In recent months, the US Food and Drug Administration (FDA) has identified more than a dozen Indian pharmaceutical manufacturers who have had problems with the data integrity practices at their respective facilities.

Categories: Active pharmaceutical ingredients, Generic drugs, Compliance, Ethics, Manufacturing, Quality, News, US, India, CDER Tags: Warning Letter, Data Integrity, India, Drug, Pharmaceutical, Data Falsification
FDA Finds Falsified Data, Serious Mold and Decaying Frogs at Pharmaceutical Company

For at least the 12th time since May 2013, the US Food and Drug Administration (FDA) has sent a Warning Letter to an Indian pharmaceutical manufacturer accusing it of falsifying data used to support the ongoing approval of its drug products.

Categories: Audit, Compliance, Ethics, Manufacturing, Quality, News, India, CDER Tags: Data Falsification, Data Integrity, Warning Letter
Regulatory Recon: Does the Government Have an Inconsistent Story on Ebola? (19 August 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 Reconnaissance: Industry Weighs in on FDA’s Biosimilars Guidance (15 August 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
New FDA Pilot Program Wants to Make Keeping Track of Device Submissions Simple

A new early-stage pilot program quietly under development by the US Food and Drug Administration (FDA) hopes to make it easier for medical device companies to see how their device is progressing through the agency's regulatory processes, all at a glance.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, US, CDRH Tags: CRD Submission Tracker, CDRH Submission Tracker Pilot Program, Nelson Anderson
What Should a New Drug be Named? FDA Gives Industry More Time to Weigh in on Proposed Changes

US regulators are giving the pharmaceutical industry more time to weigh in on a draft guidance released in May 2014 that seeks to establish how new drug products are given their "brand" names.

Categories: Labeling, Submission and registration, News, US, CDER Tags: Proprietary Name, Non-Proprietary Name, Guidance, Draft Guidance, Extension, Comment Period, Drug Naming Guidance
FDA, in Midst of Developing Biosimilars Policy, Seeks Permanent Medical Policy Director

The US Food and Drug Administration (FDA) is seeking a new director for the Center for Drug Evaluation and Research's (CDER) Office of Medical Policy (OMP).

Categories: News, US, CDER Tags: OMP, Office of Medical Policy, Job, Director
IMDRF Moves Forward With Effort to Standardize Global Device Submissions

The International Medical Device Regulators Forum (IMDRF) has released two final documents that, once implemented, should make it much easier to get medical device products approved in multiple regions, including the US, EU and Canada.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, US, Canada, Europe, Japan, China, IMDRF Tags: RPS, Regulated Product Submission, Harmonization, Table of Contents, RPS ToC
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