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1,251 Results
Type: News
Section: Industry News > Regulatory
Packaging/Filling
Meeting looming pharma serialization requirements with off-the-shelf technology
A high-speed case packer has been outfitted with serialization equipment for aggregation with less integration time.
November 9, 2016
A high-speed case packer has been outfitted with serialization equipment for aggregation with less integration time.
Pharmaceuticals
Investors Sue Over Botched Libido Drug Marketing
Sprout Pharma says Valeant didn’t make good on their marketing promise of female libido drug Addyi.
November 9, 2016
Addyi / Photo: Sprout
Pharmaceuticals
A Personal Perspective on Serialization
With the U.S. serialization deadline only a year away, compliance is crucial, especially for patients whose lives may depend on the very medications requiring serialized codes.
November 8, 2016
Optel Vision's Mario Simard (at podium) and Steve Peterson co-presented 'Serialization-Regulatory Compliance' on Tuesday, Nov. 8
Labeling/Printing
Live From Pharma EXPO: Optel Vision's Serialization Solutions
Optel Vision showed off their track and trace solutions for carton labeling, inspection and report generation.
November 8, 2016
Manual Print Station™ / Image: Optel Vision
Traceability/Serialization
RM2 Launches a Smart Pallet, Uses AT&T's LTE-M to Harness IoT
RM2ELIoT, a fully integrated, zero maintenance, long-life, IoT-based track and trace solution uses AT&T’s LTE-M network to boost connections for IoT.
November 8, 2016
RM2ELIoT, a fully integrated, zero maintenance, long-life, IoT-based track and trace solution uses AT&T’s LTE-M network to boost connections for IoT.
Regulatory
Does Music Unlock Pain Med Potential?
New report shows patients experience less pain when pairing music therapy with traditional medication.
November 8, 2016
Music Therapy / Photo: memorycareliving.com
Materials
Considerations for Implementing Single-Use Filling Systems
More targeted medical treatment therapies push the single-use systems option for fill/finish operations.
November 7, 2016
Bosch
Labeling/Printing
How Invisible Code Supports Internal Pharma Supply Chain Traceability
Videojet demonstrates at PACK EXPO how invisible codes can assist in anti-counterfeiting, track and trace and serialization issues.
November 7, 2016
Videojet demonstrates at PACK EXPO how invisible codes can assist in anti-counterfeiting, track and trace and serialization issues.
Inspection
New Image-Based Blister Testing
Non-destructive leak detection technology for pharmaceutical blister packaging boasts new and improved test time, data management and test sensitivity.
November 7, 2016
Sepha's VisionScan System
Pharmaceuticals
FDA: 21 Grants Awarded for Development of Products for Rare Diseases
The Orphan Products Clinical Trials Grants Program awarded over $23 million in grants to academia and industry. Many of the grants target cancer, pediatric needs.
November 4, 2016
Forty-three percent of the FDA's 2016 awards fund studies that enroll pediatric patients as young as newborns.
Pharmaceuticals
Chinese Drug Companies Hiding Ingredients Warns FDA
U.S. regulators barred from inspections as they take on Chinese pharmaceutical companies with questionable practices.
November 3, 2016
Chinese drug makers at Milan trade show without certification. Photo: NYT
Supply Chain
Survey Shows Confidence Gaps Among Hazmat Transport Pros
Findings indicate concern the corporate suite is not forward-thinking related to the business impact of hazmat shipping compliance, and that supply chain partners are not keeping up with regs.
November 2, 2016
Findings indicate concern the corporate suite is not forward-thinking related to the business impact of hazmat shipping compliance, and that supply chain partners are not keeping up with regs.
Adherence/Delivery
FDA Opioid Action Plan Includes Packaging, Labeling
Agency “Voice Blog” says FDA would help fund the development of assessment tools to evaluate packaging, storage, delivery, and disposal solutions designed to prevent or deter misuse and abuse of opioid analgesics.
November 1, 2016
New FDA logo
Pharmaceuticals
Global Counterfeiting Reaches $1.5 Trillion Annually
PMMI takes a close look at the counterfeiting trend and outlines ways brands can protect themselves and consumers.
October 28, 2016
Counterfeit Drugs / Image: Economist
Adherence/Delivery
RxPense Helps Seniors Take Meds on Time, Every Time
Medipense and distribution partner Rx-V launch RxPense, which automates the dispensing of pharmacist-filled blister-packaged medications and increases medication adherence.
October 27, 2016
Medipense and distribution partner Rx-V launch RxPense, which automates the dispensing of pharmacist-filled blister-packaged medications and increase medication adherence.
Medical Device/Packaging
TeleFlex Tracheostomy Tube Set Recall
TeleFlex Medical recalls tracheostomy tube sets that could cause brain damage and death.
October 24, 2016
Tracheostomy Device / Photo: Mehta
Medical Device/Packaging
FDA Addresses Medical Device Tubing Misconnections
Often packaged together or co-packaged with other devices, tubing sets can be connected improperly, causing meds or other substances to be delivered through the wrong tubing into the incorrect area of the body.
October 20, 2016
Often packaged together or co-packaged with other devices, tubing sets can be connected improperly, causing meds or other substances to be delivered through the wrong tubing into the incorrect area of the body.
Supply Chain
The EMVO’s Centralized Approach to Meeting the Falsified Medicines Directive
With the 2019 EU-FMD deadline looming, this non-profit has created a centralized hub for manufacturers and countries to connect to in the effort to streamline verification of medicinal products in Europe.
October 20, 2016
Current potential for blueprint acceptance across the EU.
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