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172 Results
Type: Blog
Section: Industry News
Regulatory
FDA Enforcement Shows Little Change with New Administration
Do the agency’s 2017 enforcement statistics reflect a new anti-regulation philosophy? Not so far, but maybe wait till next year!
February 19, 2018
Cannabis
Pot (Policy) Causes (More) Disorientation
In a realm already marked by inconsistency and uncertainty, the Trump administration makes a surprise change in policy that only adds to the confusion.
January 12, 2018
Medical Device/Packaging
Focus on Data Quality to Prepare for Class III UDI Implementation
Medical device firms need to consider their data strategy and ensure the right structure is in place for establishing clean UDIs in order to contribute to patient safety.
November 3, 2017
Pharmaceuticals
Drug Companies Transfer Patents to Native American Tribes
Questions swirl around the revolutionary practice, which is intended to simplify drug makers’ defenses of their patents, but may not be upheld as legally valid.
October 31, 2017
Pharmaceuticals
Will Serialization Truly Secure the Pharmaceutical Supply Chain?
As the pharmaceutical industry continues to invest in resources to meet DSCSA compliance deadlines, one industry professional questions whether serialization can resolve the problem of counterfeits.
September 15, 2017
Regulatory
No Package is an Island
Drug and device packaging consultant emphasizes the interconnectedness of packaging with other aspects of GMP and quality systems programs.
August 25, 2017
Adherence/Delivery
How Package Design Strategies Can Increase Patient Adherence
Containment, communication and transportation areas offer manufacturers ways to build patient adherence-increasing features.
August 8, 2017
Regulatory
FDA Releases Guidance on CR Packaging
Agency’s effort aims to help ensure CRP statements on drug labels are clear, useful, informative and consistent.
August 4, 2017
Pharmaceuticals
How to Avoid the 5 Common Pharma Packaging Artwork Hurdles
Regulatory compliance and patient safety are top priorities, but packaging and labeling errors can lead to recalls, monetary loss and delays to market.
August 1, 2017
Regulatory
To Regulate, or Not to Regulate
Despite powerful rhetoric to the contrary, there are signs and portents of somewhat conventional regulatory activities.
July 20, 2017
Cannabis
Statement of Emergency: Nevada Marijuana Supply
With product moving fast in its first weeks of sale, the state faced a supply chain bottleneck that threatened dispensaries' operations.
July 18, 2017
Pharmaceuticals
3 Ways Technology is Transforming the Life Sciences/Healthcare Supply Chain
Regulations may suppress technology uptake in some activities, but here are three ways regs are accelerating technology transformation.
May 31, 2017
Traceability/Serialization
Rumors Around the Industry: What’s Happening with Serialization Deadlines?
No word, official or otherwise, has come out regarding a delay in serialization deadlines, but will that remain the case?
May 26, 2017
Regulatory
FDA Commissioner: ‘More Forceful Steps’ Needed to Stem the Opioid Crisis
President Trump’s pick, Dr. Scott Gottlieb, establishes an Opioid Policy Steering Committee, raising prescription and policy questions.
May 24, 2017
Traceability/Serialization
Death Row Records
The execution fiasco in Arkansas left drug manufacturers scrambling to figure out how the state's Department of Correction got their hands on a supply of lethal injection drugs. Could serialization have helped?
May 15, 2017
Regulatory
With New FDA Head, Expect Activism
Dr. Scott Gottlieb, who has worked at FDA before, is a doctor and medical products investor. He comes in with very specific ideas for change.
May 9, 2017
Adherence/Delivery
The Future of Pharma Packaging Looks Smart
Patient safety issues, counterfeit drugs could make the pharmaceutical industry a trailblazer in smart packaging.
April 20, 2017
Traceability/Serialization
Serialization Standards for the Plant
OPEN-SCS is solving how to seamlessly exchange serialization data between packaging lines by leveraging existing plant floor standards. The group promises that their work will result in an open global specification accessible to large and small manufacturers.
March 21, 2017
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