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51 Results
Type: Blog
Section: Industries > Medical Devices
Pharmaceuticals
Have you come to grips with good design?
Good design takes into account real people in real-life situations.
November 12, 2015
Medical Device/Packaging
Six Considerations for Providers to Maximize the FDA UDI Final Rule
Associating a unique identifier with a medical device is a crucial step toward increasing traceability, transparency, and accuracy across the healthcare supply chain.
November 9, 2015
Pharmaceuticals
What’s a regulatory crime?
Violations of the FDA’s requirements can put you in jail for a misdemeanor even if you didn’t intend to commit them.
September 21, 2015
Pharmaceuticals
FDA: Tougher or more lenient?
The figures on their enforcement are interesting, but it’s not always clear what message they send.
July 29, 2015
Pharmaceuticals
When FDA is a cop
A quick, effective response to FDA can prevent serious consequences.
April 23, 2015
Adherence/Delivery
FDA's Hamburg's resignation
She served almost six years, juggled the agency’s varied responsibilities effectively, and her successor will continue to face varied challenges.
March 19, 2015
Package Design
Are biohazard pressure bags meeting federal regulations?
Flexible packaging company encourages medical labs to seek independent testing to ensure compliance.
January 28, 2015
Pharmaceuticals
Accessibility of medical packaging: learning from people with impairments
Manufacturers must be aware of the wide range of impairments that can affect consumers, which means one design of accessible packaging may not be suitable for all.
January 22, 2015
Pharmaceuticals
A common-sense perspective on UDI and DSCSA
In this Q&A, Chip Meyers, VP, Corporate Public Affairs, UPS, offers perspective on serialization and track and trace for medical devices and pharmaceuticals.
November 17, 2014
Pharmaceuticals
UDI vs the DSCSA
The FDA's enforcement of these two regulations could be different, because of where they originated.
November 3, 2014
Medical Device/Packaging
Navigating FDA recall requirements
A medical device recall by any other name might still stink for your company.
October 31, 2014
Materials
USP to roll out information chapters on Good Distribution Practices
Five new general chapter standards related to GDP to become official next year, when three new chapters will be proposed.
September 8, 2014
Medical Device/Packaging
Tanning product order colors understanding of law
Shedding light on how and why FDA can regulate sunlamp products.
July 2, 2014
Medical Device/Packaging
Designing for the patient journey
Design and packaging of drug delivery products requires insights into the cognitive, physical, and emotional needs of patients during the course of treatment.
June 9, 2014
Materials
Welcome to the world of therapeutic foods
What do you think of when you think of food? Holiday meals with family? Things that taste good? A post-workout treat? What else could food be used for?
May 9, 2014
Materials
RxTrace: Is your drug exempt from the Federal Drug Supply Chain Security Act?
Understanding your product’s characteristics and reading certain provisions of the Drug Supply Chain Security Act are keys.
April 30, 2014
Medical Device/Packaging
How does the business of healthcare impact the environment?
Cook Medical finds that transparency between healthcare providers and suppliers yields financial and sustainability benefits.
April 22, 2014
Medical Device/Packaging
10th Anniversary issue forecasts medical advances for 2024
Ten years from now, imagine if a prescription drug or medical device could be 3D-printed by a patient at home, or at a doctor’s office, or at the local pharmacy, perhaps reducing or eliminating the need to make and package the device or pills without using today’s traditional manufacturing process. Is this scenario even possible?
April 8, 2014
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