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.

Colgate, Other Generic Companies Hit by FDA for Failure to Pay Facility Fees

The US Food and Drug Administration (FDA) this week issued an unprecedented four Warning Letters to companies, including the consumer healthcare company Colgate, for failing to pay user fees as part of the Generic Drug User Fee Act (GDUFA).

Categories: Active pharmaceutical ingredients, Generic drugs, Manufacturing, Submission and registration, News, US, CDER Tags: Warning Letter, Warning Letters, GDUFA, GDUFA Facility Fee, FDA Facility Fee, Facility Registration Fee
FDA Outlines New Communication Process for Generic Drug Companies

The US Food and Drug Administration (FDA) is out with its fourth draft guidance document under the 2012 Generic Drug User Fee Act, this time explaining the nuances of how generic drug companies can submit requests for information from the agency.

Categories: Generic drugs, News, US, CDER Tags: Controlled Correspondence, Guidance, Draft Guidance, GDUFA, FDASIA
Tropical Disease Priority Review Voucher Fee Set to Rise

The US Food and Drug Administration (FDA) is set to increase the fee it charges users of a special, transferable voucher meant to reward developers of tropical disease treatments with an expedited review process for any subsequent drug product.

Categories: Biologics and biotechnology, Prescription drugs, Submission and registration, News, US, CDER Tags: Voucher, User Fee, Tropical Disease Priority Review Voucher, Tropical Disease Voucher
FDA Initiative to Re-Label Older Drugs Hits Significant Setback: Sources

A multi-year, $26 million program launched last year by the US Food and Drug Administration (FDA) is now being partially shelved after running into significant difficulties, FDA sources tell Focus.

Categories: Prescription drugs, Generic drugs, Labeling, News, US, CDER Tags: PDLIEI, Prescription Drug Labeling Improvement and Enhancement Initiative, PDLI-EI, Contract
Senate Bill Seeks Faster, More Predictable Approvals for Time and Extent Applications

Senate legislators have released a new iteration of the Sunscreen Innovation Act, a bill which seeks to accelerate the approval of long-delayed new sunscreen ingredients in the US, which would go beyond sunscreen ingredients to overhaul part of the process used to approve over-the-counter (OTC) drugs.

Categories: Over the counter drugs, Government affairs, Submission and registration, News, US, CDER Tags: Sunscreen Innovation Act, TEA, Time and Extent Application, Monograph, Sunscreen Innovation and Other Time and Extent Applications, Congress, Bill, Legislation, Senate
Regulatory Recon: FDA's Updates NDA Notification Policy (26 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's 'TurboTax' Pilot Program for Medical Devices Expanding

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) is expanding a new pilot program that it hopes will make medical device submissions a lot less complicated and a lot more like filing taxes using TurboTax.

Categories: In vitro diagnostics, Medical Devices, News, US, CDRH Tags: eSubmission Pilot, Nels Anderson, Cardiovascular Devices, ODE, FDA TurboTax
NIH Wants Safety, Efficacy of Viagra, Epogen and Other Drugs Tested in Children

The National Institutes of Health (NIH) has released a new "Priority List" of pediatric therapeutic areas and medical products it wants the medical community—including the pharmaceutical and biopharmaceutical industries—to focus on.

Categories: Biologics and biotechnology, Prescription drugs, Labeling Tags: NIH, BPCA, PREA, Priority List, Priority List of Needs of Pediatric Therapeutics, PLNPT, Pediatric, Children, Kids
Regulatory Recon: Former FDA Commissioner Says Agency too Risk Averse (25 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 Proposes Major Update of 2001 Labeling Regulations

Australia’s Therapeutic Goods Administration (TGA) is seeking comments on multiple proposals for the first major revision of its 2001 Drug Labeling Regulations.

Categories: Labeling, News, Oceania, TGA Tags: 2001 Drug Labeling Regulations, LASA, Look-Alike, Sound-Alike
The Regulatory Remainder: What We Missed Last Week (25 August)

Try as we might here at Regulatory Focus, we occasionally set a piece of information aside with the intention of writing about it more fully, only to never get around to doing so. So without further interruption, here's a brief recap of some of the items we had fully intended to cover this week and last, but never had time to get around to.

Categories: News Tags: Regulatory Remainder
Anvisa to Develop Standards and Guidelines for Nanotechnology Products

Brazil’s national regulatory agency, Anvisa, has established a multidisciplinary Nanotechnology Committee within the agency with the mandate to develop standards and specific guidelines for the evaluation and regulation of products that use nanotechnology. 

Categories: News, Latin America and Caribbean, Anvisa Tags: Nanotechnology, Brazil
Can FDA Regulate LDTs Through Guidance? Legal Analysis Casts Doubt

In recent weeks the US Food and Drug Administration (FDA) has undertaken major steps meant to bring lab-developed tests (LDTs)—devices developed, tested and used within a single laboratory—under stricter regulatory controls. But now new questions are being raised about whether the agency is using the correct methods to enact those changes.

Categories: In vitro diagnostics, Medical Devices, Compliance, Submission and registration, News, US, CDRH Tags: Guidance, Draft Guidance, LDTs, Lab-Developed Tests, LDT Regulation
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
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