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 Releases New Electronic Submission Requirements for Biological Products

A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) outlines a new process of submitting lot distribution reports (LDRs) in electronic format.

Categories: Biologics and biotechnology, Submission and registration, News, US, CBER Tags: LDR, LDD, Lot Distribution Reports, ESG, SPL, Structured Product Labeling, Electronic Submission Gateway, eCTD
US, Canada Continue to Push for Regulatory Harmonization in the Life Sciences

US and Canadian regulators are continuing to work together to harmonize the way in which they regulate pharmaceuticals, biologics, over-the-counter drugs, medical devices and veterinary products, both governments confirmed in an update this week.

Categories: Biologics and biotechnology, Prescription drugs, Over the counter drugs, In vitro diagnostics, Medical Devices, Veterinary products, Postmarket surveillance, Submission and registration, News, US, Canada, CBER, CDER, CDRH, Health Canada, ICH, IMDRF Tags: RCC, Regulatory Harmonization, ICH, PICS, ICDRA, IPRF
Massive Recall of Medical Devices Largest Ever Recorded by FDA

A massive medical device recall reported last week by the US Food and Drug Administration (FDA) is the largest-ever single-day event on record, according to data recently made available by FDA.

Categories: Medical Devices, Packaging, Product withdrawl and retirement, News, US, CDRH Tags: Recall, Medical Device Recall, Sterility, Packaging, Class I Recall
Regulatory Recon: Novartis Data Shows Potential Megablockbuster Heart Drug (2 September 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: Judge Upholds Massive Award in Actos Lawsuit (29 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
Brazilian Device Industry Prepares for eSubmissions

Brazil's medical device industry should prepare for electronic submissions, Anvisa, Brazil's national regulatory agency, said at a 20 August 2014 meeting.

Categories: In vitro diagnostics, Medical Devices, Submission and registration, News, Latin America and Caribbean, Anvisa, IMDRF Tags: Brazil, RPS, eSubmission
NICE Recommends Biogen Idec’s Tecidera for Multiple Sclerosis

The UK’s National Institute for Health and Care Excellence (NICE) has issued final guidance recommending Biogen Idec's multiple sclerosis drug, dimethyl fumarate (Tecfidera) as a treatment option for adults with relapsing-remitting multiple sclerosis.

Categories: Prescription drugs, Reimbursement, News, Europe, NICE Tags: NICE, UK, Tecfidera, Dymethyl Fumarate, MS, Multiple Sclerosis
FDA Clarifies Syphilis Screening Procedures for Blood, Plasma Donations

A new guidance document issued by the US Food and Drug Administration (FDA) finalizes an earlier draft set of recommendations on how blood and plasma collection centers can screen donors and samples for syphilis.

Categories: Blood, News, US, CBER Tags: Guidance, Final Guidance, HCT/P, Blood, Source Plasma, Blood Donation, Blood Donor, Screening, Syphilis
Pharmaceutical Industry Praises FDA Reprint Guidance, but Wants Agency to go Further

Earlier this year, the US Food and Drug Administration (FDA) released a much-anticipated draft guidance document which could potentially expand the ways in which pharmaceutical and medical device companies could distribute information regarding the safety of their products, even if that information isn't for an FDA-approved indication.

Categories: Biologics and biotechnology, Prescription drugs, Labeling, News, US, CDER Tags: PhRMA, Reprint Guidance, First Amendment, Free Speech, Guidance, Draft Guidance
Regulatory Recon: How Social Media Complicates Compassionate Use (28 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 Guidance Aims to Clarify Development of Medical Countermeasures

A new final guidance document issued by the US Food and Drug Administration (FDA) aims to make it easier to develop in vitro diagnostic devices (IVDs) intended to act as microbiological or medical countermeasures.

Categories: In vitro diagnostics, Clinical, Research and development, News, US, CBER, CDRH Tags: HMDD, IVD, Nuclear Acid Based Diagnostic Devices, Guidance Document, Guidance, Final Guidance, Medical Countermeasure, Microbiological Countermeasure
As Ebola Catches Attention of Congress, FDA Emergency Preparedness Bill Becomes Campaign Fodder

In March 2013, US President Barack Obama quietly signed into law the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA), a biodefense bill which gave the US Food and Drug Administration (FDA) new authority to preemptively prepare for potential pandemics or biological threats.

Categories: Government affairs, News, US Tags: PAHPRA, Pandemic and All-Hazards Preparedness Reauthorization Act, Biodefense, Campaign Ad
Merck's Insomnia Drug Belsomra Clears Final DEA Hurdle

The US Drug Enforcement Administration (DEA) has given a final and long-awaited approval to Merck to market its new insomnia drug Belsomra (suvorexant) as a Schedule IV drug.

Categories: Prescription drugs, Submission and registration, News, US Tags: Merck, Suvorecant, Belsomra, DEA, Schedule IV, CSA, Controlled Substances Act
Regulatory Recon: Huge Win for FDA in Apotex Import Ban Case (27 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 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
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
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