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1,251 Results
Type: News
Section: Industry News > Regulatory
Nutraceuticals/Dietary
Regeneca Recalls Everything (No, Really)
Regeneca Worldwide has conducted a nationwide recall its entire line of herbal and dietary supplement products.
March 15, 2017
Regeneca / Image: Regeneca
Traceability/Serialization
Track-and-Trace—a Challenge for IT
Successful serialization depends on integration with resident IT systems.
March 13, 2017
Successful serialization depends on integration with resident IT systems.
Materials
Plastic Bottles, Injectables Driving Global Pharmaceutical Packaging
New MarketsandMarkets report forecasts solid pharmaceutical packaging market growth through 2021.
March 10, 2017
New MarketsandMarkets report forecasts solid pharmaceutical packaging market growth through 2021.
Pharmaceuticals
Wake Up to Urinate Too Often? Allergan’s Got Your Back.
FDA approves the first treatment to combat nighttime trips to the bathroom: a nasal spray that decreases urine production.
March 9, 2017
Noctiva / Image: Business Wire
Packaging/Filling
AB BioTechnologies Selects Aseptic Filling Workcell and Lyophilizer Loader
The pharmaceutical contract development and manufacturing services company will reportedly be the first to operate a complete Vanrx system that includes the SA25 aseptic filling workcell, accumulator and lyophilizer loader.
March 9, 2017
AB BioTechnologies will use the SA25 Workcell to aseptically fill vials, syringes and cartridges. There is an increasing need for flexibility as pharmaceutical companies develop high-value therapies focused on smaller patient populations.
Materials
Serialization-Ready on a Global Scale
Outsourcing provider PCI Pharma Services triples serialization capacity across its global supply network to support clients in advance of meeting both U.S. DSCSA and E.U. FMD implementation dates.
March 6, 2017
Outsourcing provider PCI Pharma Services triples serialization capacity across its global supply network to support clients in advance of meeting both U.S. DSCSA and E.U. FMD implementation dates.
Materials
FDA Announces New Framework for Pharmaceutical Inspections
New agreement means U.S. and E.U. regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
March 2, 2017
The U.S. and the European Union (E.U.) completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 U.S.-EU Mutual Recognition Agreement. Under this agreement, U.S. and E.U. regulators will be able to utilize each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
Cannabis
ASTM International Unveils New Cannabis Committee
Global standards organization’s Board of Directors will receive a recommendation to approve the committee. If approved, the committee plans to host its first official meeting in the coming months.
March 1, 2017
Dr. Ralph Paroli was voted to serve as the first Chairman of a new committee focused on creating technical standards and guidance materials for cannabis and its products and processes.
Medical Device/Packaging
FDA Debunks Cybersecurity Myths
The FDA’s senior program manager for medical device cybersecurity weighs in on 4 common medical device regulatory myths.
March 1, 2017
FDA Debunks Med Device Cybersecurity Myths
Pharmaceuticals
“Latex Free” Products May Contain Latex. Wait, What?
Advanced Pharma recalls sterile injectable products labeled “latex free” because they might contain synthetic or natural latex.
February 28, 2017
Avella Specialty Pharmacy / Image: Avella
Temp Control/Cold Chain
Healthcare Packaging & Processing Conference Features ASTM, Open-SCS Updates and More
With regulation deadlines looming and new developments in test methods, speakers offered expert advice on serialization, packaging standards, cold chain distribution and more.
February 28, 2017
The Healthcare Packaging & Processing Conference (Feb. 27 and 28) at the Pennsylvania Convention Center, co-located with PACK EXPO East in Philadelphia, featured speakers with a wide variety of expertise.
Pharmaceuticals
Endo Recalls Erectile Dysfunction Injection
Endo Pharmaceuticals Inc. voluntarily recalls one lot of Edex due to potential lack of sterility assurance.
February 28, 2017
Endo's Edex Injection / Image: edguidance.com
Pharmaceuticals
Serialization Event for CMOs, CPOs and 3PLs
Two interactive days in Princeton, NJ, aim to assist key pharmaceutical manufacturers, CMOs, CPOs and 3PL’s achieve cost-effective compliance with November DSCSA serialization deadline.
February 28, 2017
The April 4-5 Pharma CMO Summit gathering is the latest iteration in a series of such summits organized by Supply Chain Wizard.
Materials
Medication Errors Prompt Advanced Technologies in Pharmacy Repackaging
The rise in the number of outpatient visits has encouraged pharmacists and hospitals to incorporate automated systems to improve their prescription handling capacity.
February 21, 2017
The rise in the number of outpatient visits has encouraged pharmacists and hospitals to incorporate automated systems to improve their prescription handling capacity.
Adherence/Delivery
Cold Form Blisters Provide Barrier Protection, Safety, Shelf Life Benefits
Grand View Research report forecasts the global cold form blister packaging market to reach US$ 8.63 billion by 2024, with healthcare accounting for 48% of volume in 2015.
February 17, 2017
Grand View Research report forecasts the global cold form blister packaging market to reach US$ 8.63 billion by 2024, with healthcare accounting for 48% of volume in 2015.
Materials
New Developments in Pharma Packaging and Drug Delivery
Pharmapack Europe trends include ‘human factor’ principles, with individualized packaging and serialization as integral future solutions.
February 16, 2017
During Pharmapack Europe 2017, Nemera’s Safelia® earned the award for Best Exhibitor Innovation for “Patient Centricity & Customization.”
Medical Device/Packaging
J&J Sued Over Leaking Breast Implants
A California woman sued Johnson & Johnson and two subsidiaries after leaking silicone breast implants caused muscle pain and nausea.
February 9, 2017
Mentor Silicone Implant / Photo: PR Newswire
Regulatory
Packaging Issue Prompts Marijuana Condiment Recall
An Arizona-based medical marijuana dispensary is recalling four weed-infused condiments due to packaging and pathogen concerns.
February 8, 2017
Flourish Marijuana Marinara / Photo: Flourish Cannabis
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