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1,882 Results
Section: Industry News > Regulatory
Adherence/Delivery
21 Critical Cell Therapy Supply Chain Tips
From holiday weekends to large health center campuses, find out where risk may be lurking in the collection, manufacturing and delivery of cell therapies.
July 11, 2019
Regulatory
For Opioid Solutions, the Law Points to Packaging
FDA singles out a specific form of drug packaging in a proposed part of its efforts to stem the tide of opioid addiction.
July 10, 2019
Pharmaceuticals
Altaire Recalls Eye Drops & Ointments Sold at Walgreens
Altaire Pharmaceuticals is recalling multiple eye care products exclusively produced for and sold at Walgreens due to sterility concerns.
July 10, 2019
Medical Device/Packaging
Medtronic Insulin Pumps Recalled Due to Cybersecurity Concerns
The FDA is warning patients and healthcare providers that Medtronic MiniMed insulin pumps have potential cybersecurity issues.
July 4, 2019
Pharmaceuticals
Pfizer Combats Counterfeited Viagra in Hong Kong
Through serialization technology, pharmaceutical company Pfizer was able to target the distribution of counterfeit Viagra in Hong Kong.
June 26, 2019
Regulatory
FDA Guidance: Providing Regulatory Submissions for Promotional Labeling and Advertising Materials
Final guidance includes seven examples of appropriately submitted promotional materials, including video games, exhibit booth banners, and kit materials.
June 21, 2019
Pharmaceuticals
Studies Say Healthy People Should Take Daily HIV Drug
New guidelines suggest healthy people at risk of HIV should take a daily prevention pill to reduce risk or infection.
June 19, 2019
Pharmaceuticals
Critics Question Ketamine Nasal Spray for Depression
The FDA approved Spravato to treat intractable depression, but only after limited trials that provided minimal evidence it actually worked.
June 14, 2019
Regulatory
DSCSA: Post-Serialization Depression & What’s to Come
Over 18 months since the DSCSA (Drug Supply Chain Security Act) came into effect, manufacturers continue to struggle with Post-Serialization Depression (PSD).
June 11, 2019
Nutraceuticals/Dietary
FDA Says Weight Loss Supplement Could Cause a Miscarriage
The Agency warns that an ingredient in certain weight loss and energy supplements may lead to a miscarriage.
June 11, 2019
Traceability/Serialization
Q&A: The Impact and Benefit of Serialization on Rare Disease Therapies
At FutureLink Barcelona 2019 in June, the serialization discussion will focus on the value of digital information sharing Can healthcare manufacturers use data to help patients and physicians?
June 7, 2019
Regulatory
Live from AIPIA: RFID Tags Could Save the U.K. National Health Service $500M/year
Diagnostic samples bound for one of the U.K.’s NHS pathology labs get a reusable storage system and low-cost RFID labels that save packaging, staff, and operational costs, among other benefits.
June 6, 2019
Pharmaceuticals
FDA Approves Most Expensive Drug in History
The FDA just approved a new drug to treat a rare and deadly genetic disorder, and it costs more than $2 million.
June 5, 2019
Traceability/Serialization
Contract Packaging Organization Digitizes Supply Chain Operations
Central Pharma selected the Veratrak platform to help achieve digitized end-to-end visibility of the supply chain and improve collaboration.
June 4, 2019
Pharmaceuticals
Supreme Court Sides with Merck on Warning Label Issue
The FDA blocked Merck’s attempt to add a femoral fracture warning to its osteoporosis drug Fosamax.
May 31, 2019
Medical Device/Packaging
SCANDAL: FDA Hides 50k Heart Device Malfunction Reports
An investigation revealed the FDA allowed a faulty implantable heart device to covertly log 50,000 malfunction incidents without action.
May 30, 2019
Regulatory
Part 2: Tips for Revamping Your Artwork Approval Process
Overhauling the artwork approval process? A senior labeling manager at Bausch Health shares tips about what to consider before you start including allocating resources and time, and the importance of work instructions.
May 22, 2019
Regulatory
Part 1: Tips for Revamping Your Artwork Approval Process
Overhauling the artwork approval process? A senior labeling manager at Bausch Health shares tips about what to consider before you start.
May 21, 2019
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