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Search: Page 40

1,251 Results
Type: News
Section: Industry News > Regulatory
Traceability/Serialization
FDA will not penalize for non-compliance of tracing policy
The move was made in an effort to minimize possible disruptions in the distribution of prescription drugs in the U.S.
December 29, 2014
Nutraceuticals/Dietary
FDA: Three sexual enhancement pills tainted
The undeclared ingredient is known to interact with nitrates found in some prescription drugs.
December 23, 2014
Nutraceuticals/Dietary
Controlled substance found in herbal supplement prompts recall
B-Lipo Capsules are marketed as a natural supplement for weight loss.
December 23, 2014
Hp 28748 Ucm427659
Materials
Top 30 pharmaceutical firms spent $112 billion on R&D in 2013
Advancing pipeline programs into later-stage clinical trials boosts spending, but many companies reduced their workforces to help stabilize profits in the aftermath of patent losses.
December 18, 2014
The world’s leading 30 pharmaceutical companies spent a combined $112 billion on research and development (R&D) in 2013, an increase of $723 million over the previous year, according to research and consulting firm GlobalData.
Regulatory
November 2014 FDA Safety Labeling Changes
The list includes 30 products.
December 17, 2014
Medical Device/Packaging
FDA expected to 'meet or exceed' trial approval deadlines
The self-imposed deadline is expected to help advance medical technology by approving trails faster.
December 16, 2014
Materials
Quality risk management: an industry/regulatory perspective
Examining the different approaches for the traditional qualification model and the risk-based system now being encouraged by regulators.
December 16, 2014
Examining the different approaches or the traditional qualification model and the risk-based system now being encouraged by regulators.
Pharmaceuticals
Patent cliff to cause $65 billion sales loss
Expiries of leading drugs to cause huge financial losses for pharmaceutical firms by 2019, predicts GlobalData.
December 10, 2014
Expiries of leading drugs to cause huge financial losses for pharmaceutical firms by 2019, predicts GlobalData.
Pharmaceuticals
Is the FDA stalling on biosimilars?
Lawmakers want the FDA to move quickly when it comes to biosimilars.
December 4, 2014
Pharmaceuticals
FDA updates drugs/biologics labeling system
Includes major revisions on pregnancy and breastfeeding, with labeling changes taking effect June 30, 2015. Prescription drugs and biologic products approved after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
December 3, 2014
Source: U.S. Food and Drug Administartion, “Pregnancy and Lactation Labeling Final Rule,” 12/3/14
Medical Device/Packaging
Who should be accountable for medical device and healthcare cybersecurity?
In the recent letter to the FDA, the American Hospital Association believes the responsibility lies with medical device manufacturers.
December 3, 2014
Regulatory
Infant's death prompts CDC investigation, recall of probiotic
The distribution of Solgar ABC Dophilus Powder probiotic product has been suspended.
November 24, 2014
Regulatory
Gabapentin Capsules recalled by Aurobindo Pharma USA
The lot is said to contain come empty capsules.
November 24, 2014
Pharmaceuticals
FDA issues guidance for outsourcing facilities
Aims to assist entities that compound sterile human drugs; available for comment in Federal Register for 60 days.
November 21, 2014
Aims to assist entities that compound sterile human drugs; available for comment in Federal Register for 60 days.
Package Design
Baxter recalls Highly Concentrated Potassium Chloride Injection
The voluntary recall was prompted because of mislabeled overpouch.
November 21, 2014
Medical Device/Packaging
DePuy Synthes, Stryker, Medtronic speakers highlight HealthPack 2015
Topics to be covered March 3-5, in Virginia Beach will include technology for manufacturing innovation, package design, sealing process validation, and a local operating nurse panel.
November 14, 2014
Topics to be covered March 3-5, in Virginia Beach will include technology for manufacturing innovation, package design, sealing process validation, and a local operating nurse panel.
Robotics/Automation
Five best practices in serialization solution architecture
Pharma EXPO presenter addresses key architectural and organizational questions that manufacturers need to consider in building serialization programs.
November 12, 2014
Pharma EXPO presenter addresses key architectural and organizational questions that manufacturers need to consider in building serialization programs.
Regulatory
Shift in Congress gives hope to repeal of medical device tax
At minimum, a reduction of the medical device tax could happen as the GOP takes over the Senate, analysts predict.
November 9, 2014
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