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1,251 Results
Type: News
Section: Industry News > Regulatory
Medical Device/Packaging
FDA Approves Surgical Augmented Reality
Microsoft’s HoloLens augmented reality system projects 2D, 3D, and 4D images onto a patient’s body to help physicians plan surgery.
November 20, 2018
Medical Augmented Reality / Image: Novarad
Pharmaceuticals
FDA Cracks Down on StemGenex for a Myriad of Issues
The San Diego-based biologic company was marketing an unapproved stem cell product manufactured in a questionable facility.
November 19, 2018
StemGenex Facility / Image: StemGenex
Pharmaceuticals
Clinical Trial Offers Hope for HIV Cure
Gammora is a treatment intended to kill HIV-infected cells rather than suppress the spread of the virus.
November 13, 2018
HIV Invected Cell / Image: Zion Pharma
Regulatory
Tamper Evident Labels Market to Surpass $7 Billion in Next 10 Years
A new Fact.MR Study shows strong growth from the pharmaceutical market, while a ‘high-speed’ market bolsters need.
November 13, 2018
According to a new Fact.MR study, the tamper evident labels market is expected to surpass $7 billion by 2028 due to demand from the pharmaceutical industry.
Materials
FDA Announces New Inspection Protocol Project
For sterile injectable drugs, NIPP is reported as the first in a planned series of new inspection protocols covering all dosage forms. Agency’s goal is for full implementation within two years.
November 9, 2018
For sterile injectable drugs, NIPP is reported as the first in a planned series of new inspection protocols covering all dosage forms. Agency’s goal is for full implementation within two years.
Pharmaceuticals
FDA Approves Opioid 1,000x Stronger Than Morphine
The FDA says that Dsuvia is necessary to provide pain relief to soldiers, but critics are wary of a drug that powerful.
November 9, 2018
Dsuvia Single Dose Packaging / Image: Dsuvia
Pharmaceuticals
Blood Pressure Drug Recalled Due to Cancer Risk
Irbesartan tablets have been recalled due to the presence of an impurity believed to cause cancer.
November 6, 2018
Irbesartan / Image: Stada
Supply Chain
Verification Router Service Moves from Theoretical to Practical
Work advances on look-up directories and testing. Live poll results show that most manufacturers plan to respond to requests using a solution provider participating in a VRS network.
November 6, 2018
A network of interoperable solutions used to manage the acceptance, formatting, and delivery of requests and responses in order to support DSCSA verification requirements. (Source: HDA)
Regulatory
An Eye Scan Could Detect Early Alzheimer’s
Results from two studies suggest signs of Alzheimer’s are detectable in the small blood vessels in the retina before symptoms appear.
November 1, 2018
Optical coherence tomography angiography / Image: medgadget
Adherence/Delivery
New Opioid Crisis Law Cites Unit-Dose Packaging
President signs Support for Patients and Communities Act into law; HCPC applauds efforts of Congress and the FDA.
October 26, 2018
President signs Support for Patients and Communities Act into law; HCPC applauds efforts of Congress and the FDA.
Nutraceuticals/Dietary
FDA Finds Undeclared Sibutramine in Zero Xtreme
Fat Burners Zone issues a voluntary nationwide recall of a weight loss product tainted with an appetite suppressant.
October 22, 2018
Zero Xtreme / Image: Vanguardia Liberal
Pharmaceuticals
HDA Survey Indicates DSCSA Readiness Progress
With the Nov. 27, 2018 milestone almost here, respondents indicate concerns, including CMO knowledge, delayed equipment deliveries, and meeting 2019 saleable returns requirements.
October 19, 2018
With the Nov. 27, 2018 milestone almost here, respondents indicate concerns, including CMO knowledge, delayed equipment deliveries, and meeting 2019 saleable returns requirements.
Pharmaceuticals
Pharmaceutical Packaging Serialization Lagging as DSCSA Enforcement Deadline Looms
Assessments by AmerisourceBergen, Cardinal Health, and McKesson Pharmaceutical shows nearly 80% of packages do not meet requirements.
October 18, 2018
GS1 US DSCSA barcode assessment infographic.
Nutraceuticals/Dietary
FDA Creates New Category for Birth Control Apps
The new trend in birth control is smartphone apps that use basal body thermometers to determine when a woman is fertile or infertile, and one has actually been FDA-approved.
October 18, 2018
Birth Control Apps / Image: CNBC
Regulatory
Electronic ‘Smart’ Label for Clinical Trials
CCL's new label platform uses smartphone technology to improve medication adherence by engaging patients, clinicians and health organizations.
October 15, 2018
New label platform uses smartphone technology to improve medication adherence by engaging patients, clinicians and health organizations. (Image used with permission.)
Cannabis
Washington State Tells Cannabis-Infused Candy Makers to Cease Production
Washington state regulators want to put an end to marijuana gummies and hard candies that could appeal to children.
October 15, 2018
Edible Marijuana Gummies / Image: PrestoDoctor
Packaging/Filling
ESS Technologies, Antares Vision Show Serialized Case Packing System
Companies collaborate on robotic case packaging and serialization system that’s on display and operating at Booth S-3760 during PACK EXPO International.
October 14, 2018
Companies collaborate on robotic case packaging and serialization system that’s on display and operating at Booth S-3760 during PACK EXPO International.
Medical Device/Packaging
4 Ways the FDA is Improving Medical Device Security
FDA Commissioner Scott Gottlieb described the agency’s plan to improve cybersecurity to combat attacks on medical devices.
October 9, 2018
Medical Device Security
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