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172 Results
Type: Blog
Section: Industry News
Pharmaceuticals
Challenges and Benefits of Using ISTA’s Standard 20 for the Development of ISC’s
Standard 2D Revision 2.0 uses a QbD approach to develop insulated shipping containers (ISCs) to meet regulatory expectations.
March 21, 2017
Materials
Laser Coding Helps to Deter Counterfeit Meds
Within the pharmaceutical industry, the quality of labeling and coding is paramount to ensure that the end user has access to clear, concise information and to help manufacturers be compliant with national and international labeling legislation.
March 17, 2017
Regulatory
Gottlieb as FDA Head Draws Mixed Reviews
Perspectives vary concerning last week’s announcement that President Donald J. Trump intends to nominate Scott Gottlieb to be Commissioner of Food and Drugs at the Department of Health and Human Services.
March 13, 2017
Regulatory
Defect Classification: Is Harmonization Possible?
As product quality regulations become increasingly stringent, achieving uniform and quality-based criteria for classification of defects will become a collaborative effort among stakeholders.
February 13, 2017
Pharmaceuticals
New Administration, New Regulatory Direction
Could radical changes be coming to the way drugs and devices are regulated, and what impact might that have on safety and effectiveness of products in commerce?
February 10, 2017
Pharmaceuticals
Five Cold Chain Trends Shaping 2017
Heading into 2016, lifescience cold chain trends to watch included passive vs active bulk shippers and the growth of biologics and biosimilars and the patent cliff. Some of these trends will continue into 2017, but here are five additional trends shaping the lifescience cold chain.
January 19, 2017
Materials
What To Expect in Medication Adherence Packaging
In this Q&A, Walter Berghahn, Executive Director, Healthcare Compliance Packaging Council, discusses packaging, technology, and cost issues in the ongoing effort to improve patient adherence to medication regimens.
January 18, 2017
Materials
What To Expect in Medication Adherence Packaging
In this Q&A, Walter Berghahn, Executive Director, Healthcare Compliance Packaging Council, discusses packaging, technology, and cost issues in the ongoing effort to improve patient adherence to medication regimens.
January 18, 2017
Regulatory
True (Viagra) Blue
As track and trace efforts continue, researchers explore complementary avenues. The unique surface color of drugs may help people spot counterfeits through the use of colorimetry.
January 18, 2017
Materials
Holograms Play Growing Role in Track and Trace Packaging
The technology can incorporate various data forms and product tracking information, as well as link on-pack product identification with supply chain management, market enforcement and forensic support services.
January 12, 2017
Regulatory
Big Healthcare Law, With Gap
21st Century Cures Act surprises on off-label use. Law does many things, but leaves out an important topic.
January 5, 2017
Inspection
Serialization Virtual Reality Reader Delivers Unique Experience
With the first major serialization deadline less than a year away, the pharmaceutical industry is scrambling to not just comply with regulations, but to establish comprehensive traceability solutions without disrupting production.
December 6, 2016
Nutraceuticals/Dietary
Homeopathy Gets a Second Look
It usually chugs along on a path parallel to traditional medicine, but some products took center stage lately due to safety questions.
October 17, 2016
Materials
Medical Device Packaging Standards Expanding Globally
Standards aim to help manufacturers engineer devices to ensure safety and establish traceability ‘from womb to tomb.’ India and emerging markets may develop their own country-specific standards.
September 26, 2016
Medical Device/Packaging
Packaging is Part of the Guidance Package
Medical device makers might need FDA guidance more than other manufacturers.
August 12, 2016
Medical Device/Packaging
View From The Ground: UDI Implementation
A medical device consultant shares his perspective on the challenges to packagers of this new requirement.
June 24, 2016
Materials
Thinking About Single-Use Technology
The opening of JHL Biotech’s facility in China is an opportunity to address the use of new biopharmaceutical manufacturing techniques.
June 2, 2016
Materials
Can Patients Be Key to Solving Counterfeit Medicines?
Layered security measures, global standards and patient empowerment could help protect consumers and pharmaceutical manufacturers.
May 27, 2016
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