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1,251 Results
Type: News
Section: Industry News > Regulatory
Regulatory
FDA Demands 44 Vape Pods Cease Sales
The FDA continues its attack on vaping by telling manufacturers of dozens of vape pod and hookah products to stop selling items immediately.
August 15, 2019
Regulatory
FDA Intends to Deactivate Outdated Drug Listing Records as Supply Chain Security Step
“The agency has found that tens of thousands of drug listing records have not been updated or certified in the past year, and are therefore not in compliance with federal regulations…”
August 13, 2019
Pharmaceuticals
Work Through Common Implementation Challenges at HDA’s 2019 Traceability Seminar
Washington, D.C. hosts this year’s event that will feature a forum for stakeholders to plan for and discuss current and future milestones and challenges.
August 9, 2019
Regulatory
Companies Stay Alert as There’s No Obvious Slowing at FDA
One might expect these to be sleepy times at the U.S. Food and Drug Administration, seeing as how its commissioner resigned in spring, and that it’s part of an administration that has a dogmatically anti-regulatory philosophy.
August 5, 2019
Regulatory
FDA Science Forum: Sep. 11 and 12
Topics covered at ‘Transforming Health: Innovation in FDA Science’ will include labels, digital health, cannabinoids and more. It’s open to the public, industry and more. Register soon!
August 1, 2019
Pharmaceuticals
FDA Requires Black Box Warning for Pfizer Drug
Pfizer will be required to add a black box warning for Xeljanz, stating that patients who take it could experience a higher risk of blood clots or death.
July 31, 2019
Pharmaceuticals
Partnership to Develop a “Vein-To-Vein” Digital Supply Chain
Shared sources and knowledge will benefit cell and gene therapy players through standardization, scalability, and compliance.
July 31, 2019
Regulatory
Live from AHRMM: 4 Healthcare Supply Chain Trends
86% say a UDI icon or the word “UDI” next to the barcode would make it easier to identify at the point of care. Also on the agenda: RFID tracking and product storage space concerns.
July 29, 2019
Regulatory
E-Cig Companies Have 10 Months to Submit Applications to FDA
The FDA reduced the deadline for e-cigarette companies to defend why they should be able to keep selling their products.
July 24, 2019
Pharmaceuticals
First Baby Born From Transplanted Uterus From a Dead Donor
A new development in reproductive options gives infertile women due to uterine issues another chance to bear children.
July 12, 2019
Pharmaceuticals
Altaire Recalls Eye Drops & Ointments Sold at Walgreens
Altaire Pharmaceuticals is recalling multiple eye care products exclusively produced for and sold at Walgreens due to sterility concerns.
July 10, 2019
Medical Device/Packaging
Medtronic Insulin Pumps Recalled Due to Cybersecurity Concerns
The FDA is warning patients and healthcare providers that Medtronic MiniMed insulin pumps have potential cybersecurity issues.
July 4, 2019
Regulatory
FDA Guidance: Providing Regulatory Submissions for Promotional Labeling and Advertising Materials
Final guidance includes seven examples of appropriately submitted promotional materials, including video games, exhibit booth banners, and kit materials.
June 21, 2019
Pharmaceuticals
Studies Say Healthy People Should Take Daily HIV Drug
New guidelines suggest healthy people at risk of HIV should take a daily prevention pill to reduce risk or infection.
June 19, 2019
Pharmaceuticals
Critics Question Ketamine Nasal Spray for Depression
The FDA approved Spravato to treat intractable depression, but only after limited trials that provided minimal evidence it actually worked.
June 14, 2019
Nutraceuticals/Dietary
FDA Says Weight Loss Supplement Could Cause a Miscarriage
The Agency warns that an ingredient in certain weight loss and energy supplements may lead to a miscarriage.
June 11, 2019
Pharmaceuticals
FDA Approves Most Expensive Drug in History
The FDA just approved a new drug to treat a rare and deadly genetic disorder, and it costs more than $2 million.
June 5, 2019
Pharmaceuticals
Supreme Court Sides with Merck on Warning Label Issue
The FDA blocked Merck’s attempt to add a femoral fracture warning to its osteoporosis drug Fosamax.
May 31, 2019
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