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Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.
Published: 5 Dec 2019 | 23:22 UTC

The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms.

The J. M. Smucker Company Issues Voluntary Recall of  Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health Concerns
Published: 5 Dec 2019 | 23:20 UTC

The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards.

Regulators Target Diabetes Drug Metformin for NDMA Contamination
Published: 5 Dec 2019 | 23:13 UTC

Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA).

Regulators Target Diabetes Drug Metformin for NDMA Contamination
Published: 5 Dec 2019 | 23:13 UTC

Healthcare regulators have set their sights on type 2 diabetes drug metformin to see if it contains unsafe amounts of N-nitrosodimethylamine (NDMA).

FDA Approves First Gilenya Generics
Published: 5 Dec 2019 | 23:12 UTC

Novartis’ blockbuster multiple sclerosis drug Gilenya (fingolimod) may soon face generic competitors in the U.S., following three FDA approvals.

EMA Group Questions Notified Bodies Assessing Companion Diagnostics
Published: 5 Dec 2019 | 22:10 UTC

Currently, the EMA doesn’t assess companion diagnostics and genetic testing platforms, because that is handled by notified bodies.

EMA Group Questions Notified Bodies Assessing Companion Diagnostics
Published: 5 Dec 2019 | 22:10 UTC

Currently, the EMA doesn’t assess companion diagnostics and genetic testing platforms, because that is handled by notified bodies.

PharmaSwiss Recalls Emerade Adrenaline Pens
Published: 5 Dec 2019 | 22:09 UTC

The UK’s Medicines and Healthcare products Regulatory Agency advised healthcare professionals to quarantine all remaining stock and return it to the supplier.

FDA Warns New Jersey OTC Drugmaker for Quality Unit Failures
Published: 5 Dec 2019 | 21:58 UTC

The firm lacked written procedures for change controls and investigations.

What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD
Published: 5 Dec 2019 | 20:32 UTC

The FDA is working to answer questions about the science, safety, and quality of products containing cannabis and cannabis-derived compounds, particularly CBD.

Recon: Sage Depression Drug Fails in Phase III; China’s NMPA Approves Lynparza for Ovarian Cancer
Published: 5 Dec 2019 | 17:55 UTC

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

Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features, European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019
Published: 5 Dec 2019 | 14:30 UTC

Workshop on the role of registries in the monitoring of cancer therapies based on genetic and molecular features, European Medicines Agency, Amsterdam, the Netherlands, from 29/11/2019 to 29/11/2019

Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic,Spondylitis, Ankylosing,Colitis, Ulcerative,Psoriasis,Crohn Disease,Arthritis, Rheumatoid, Date of authorisation: 10/09/2013, Revision: 17, Status: Authorised
Published: 5 Dec 2019 | 10:00 UTC

Human medicines European public assessment report (EPAR): Remsima, infliximab, Arthritis, Psoriatic,Spondylitis, Ankylosing,Colitis, Ulcerative,Psoriasis,Crohn Disease,Arthritis, Rheumatoid, Date of authorisation: 10/09/2013, Revision: 17, Status: Authorised

EpiPen Jr
Published: 5 Dec 2019 | 7:00 UTC

Update on shortage

MolecuLight Receives FDA 510(k) Clearance for its i:X® Handheld Fluorescence Imaging Device for Wound Management
Published: 5 Dec 2019 | 0:00 UTC

New FDA Approval Extends Label to Including the i:X's Detection of Bacteria and Digital Wound Measurement

U.S. Tops List of Trial Startups With China Making Progress in Phase 1
Published: 4 Dec 2019 | 22:56 UTC

China is rapidly making headway in phase 1 clinical trials, although the U.S. remains the world leader in phase 1 through 3 trials overall.

VivaLnk Earns CE Mark for Multi-Vital Wearable Sensor and SDK
Published: 4 Dec 2019 | 18:59 UTC

The reusable sensor patch weighs 7.5 grams.

Tips for a successful FDA Human Factors meeting, Part One: Preparing for the meeting
Published: 4 Dec 2019 | 18:41 UTC

Meetings with the US Federal Drug Administration’s (FDA’s) Human Factors (HF) reviewers often yield helpful clarifications and a clearer path forward for a medical device’s development and/or commercialization. Those manufacturers that have attended an HF-focused meeting with FDA probably agree. But, others might feel like they have to “prepare for battle,” either because the manufacturer has a strained relationship with the Agency or a particular individual has previous experience with a contentious meeting on HF or other topics.

505(b)(2): A Pathway to Competitiveness Through Innovation for Specialty and Generic Companies
Published: 4 Dec 2019 | 0:00 UTC

As the market for specialty and generic products continues to become more competitive and pricing pressures increase, the 505(b)(2) pathway may offer an attractive alternative for companies looking to differentiate their products and diversify their portfolios. Section 505(b)(2) expressly

FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Published: 3 Dec 2019 | 20:12 UTC

South San Francisco, CA -- December 3, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy...

The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval
Published: 3 Dec 2019 | 19:05 UTC

ASCA is the Accreditation Scheme for Conformity Assessment (ASCA), which was created by the United States Food and Drug Administration (FDA) following amendments to Section 514 by the FDA Reauthorization 95 Act of 2017 (FDARA). The assessment was initiated as part of the enactment of the Medical Device User Fee 96 Amendments of 2017 (MDUFA IV).

The purpose of the ASCA program is to reduce the regulatory burden on the medical device industry through consensus of requirements for efficiency. Ideally, the ASCA “stamp of approval” would clear the first hurdle in the medical device premarket regulatory process for manufacturers submitting to the Centers for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).

When the FDA announced intention to implement a pilot program for ASCA, NAMSA became immediately involved providing feedback on the program as early as May 2017, and participating as a guest panelist during the public workshop held on May 23, 2018. With the recent release of the draft guidance entitled “Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Draft Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff” on September 20, 2019, NAMSA completed review and drafted comments for submission under the 90-day comment period.

Through our work with thousands of medical device clients, NAMSA recognizes that there are variations in test methods, parameters and report styles among the CRO community and that these can contribute to delays in the FDA review process. Based on the requirements in the draft guidance, the pilot program should eliminate these variations and provide efficiencies fulfilling the FDA objective. We are hopeful at this time that the additional accreditation responsibility added to the testing laboratory, accrediting body, and the device manufacturer will be mutually beneficial.

Lastly, we recognize that the FDA has set high-quality and scientific requirements of testing laboratories seeking accreditation.  NAMSA is positioned well for the pilot with ISO 17025 accreditation and our rich scientific foundation with more than 50 years of medical device experience.  We believe in collaborating with our clients to provide superior results while adhering to our core culture of quality.

How Can NAMSA Help?
NAMSA is the industry pioneer of medical device testing to drive successful regulatory outcomes. We offer all testing services in our state-of-the-art laboratories located throughout North America, Asia and Europe, and are continually committed to looking for ways to save clients time and reduce the overall amount of testing.

NAMSA Test Navigator
NAMSA’s Test Navigator was built to provide visibility into the breadth and depth of NAMSA’s testing capabilities. It highlights the most commonly used tests within the medical device industry and also provides thousands of unique testing services for special test and study requirements. No matter your testing goals, NAMSA can deliver a personalized, reliable and cost-effective solution for your development efforts. Access now!

The post The Evolution of the Accreditation Scheme for Conformity Assessment (ASCA) for Medical Device Premarket Approval appeared first on NAMSA.

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2019, PRAC, 29/11/2019
Published: 29 Nov 2019 | 11:00 UTC

At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of...

Evofem Biosciences Resubmits New Drug Application to U.S. FDA for Amphora® for the Prevention of Pregnancy
Published: 26 Nov 2019 | 3:11 UTC

SAN DIEGO, Nov. 26, 2019 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug...

Strengthened recommendations for the yellow fever vaccine
Published: 22 Nov 2019 | 11:03 UTC

The Commission on Human Medicines recommends further precautions for people with weakened immunity and in those aged 60 years or older.

Yellow fever vaccine: stronger precautions in people with weakened immunity and in those aged 60 years or older
Published: 21 Nov 2019 | 14:57 UTC

The Commission on Human Medicines has issued a series of recommendations to strengthen measures to minimise risk with the yellow fever vaccine (Stamaril) following very rare fatal reactions.

GAO Flags How a REMS May Slow Generics
Published: 15 Nov 2019 | 22:47 UTC

Generic drugmakers have acknowledged to the GAO that their inability to access samples of reference drugs because of distribution limitations under certain risk evaluation and mitigation strategies (REMS) delayed or discouraged them from developing generic drugs.

Withdrawn application: Luxceptar, viable T-cells, Date of withdrawal: 06/11/2019, Initial authorisation
Published: 15 Nov 2019 | 11:00 UTC

Withdrawn application: Luxceptar, viable T-cells, Date of withdrawal: 06/11/2019, Initial authorisation

HHS to Support Development of Infection Diagnostic Technology
Published: 14 Nov 2019 | 18:37 UTC

HHS will provide support under a 14-month, $6 million contract, which can be extended up to almost $65 million through 2027.

The FDA approve esketamine nasal spray for severe depression
Published: 8 Mar 2019 | 16:00 UTC

Federal regulators have approved the use of the new prescription nasal spray drug esketamine for depression that has not responded to other treatments.

What are Medicare and Medicaid?
Published: 4 Dec 2018 | 8:00 UTC

Medicare and Medicaid are state- and federal-funded health insurance plans that enable people with a low income to access healthcare in the United States. Find out more about what they are, the plans available, and who can access them.



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