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1,251 Results
Type: News
Section: Industry News > Regulatory
Regulatory
Young Blood Transfusions To Reverse Aging? Sign Me Up!
A new startup provides blood transfusions from young people to improve cognitive and neurological functions.
June 15, 2017
Blood transfusions can reverse aging. / Image: HBO
Pharmaceuticals
FDA Tells Endo to Pull Opioid Opana ER From Market
The FDA says the benefits of Opana Pharmaceuticals’ extended-release painkiller no longer outweigh the risk of abuse.
June 14, 2017
Opana ER / Image: Rich Pedroncelli
Pharmaceuticals
Birth Control Might Make Women Pregnant. Wait, What?
One lot of Mibelas birth control was recalled because the placebo pills were inserted at the beginning of the pack instead of at the end.
June 13, 2017
Mirabelas Birth Control Packaged Correctly / Image: Mirabelas
Pharmaceuticals
Opioid Epidemic Bigger Threat Than Terrorism
Politicians spend trillions of dollars on foreign wars while neglecting a very real issue on American soil: the opioid epidemic.
June 8, 2017
Celebrities who have died from opioids. / Image: RealLeaders
Regulatory
FDA: Delayed UDI Compliance Dates for Class I and Unclassified Devices
For lower risk devices, new compliance dates will extend into 2020 and 2022.
June 6, 2017
For lower risk devices, new compliance dates will extend into 2020 and 2024.
Pharmaceuticals
Aussie Plant Kills 100% of Zika in Cells
Researchers in Queensland are using a compound from a native plant to stop the Zika virus from replicating and affecting host cells.
June 5, 2017
Zika is spread by mosquitos. / Image: AP
Medical Device/Packaging
Abbott Recalls HeartMate II After 26 Deaths
Abbott Laboratories recalls more than 28,000 HeartMate II blood pumps due to complications while exchanging controllers.
June 2, 2017
HeartMate II / Image: Thoratec
Pharmaceuticals
In Obvious News: Cranberries are NOT Medical Devices
The European Commission’s regulatory committee decides that cranberry products used to prevent and treat bladder inflammation are not medical devices.
May 31, 2017
Cranberry Medical Device? / Image: LiveStrong.com
Pharmaceuticals
FDA Approves First Drug for Solid Tumors
The Food and Drug Administration has approved a groundbreaking immunotherapy drug to treat solid tumors anywhere in the body.
May 30, 2017
T-cells which are activated to fight cancer by Pembrolizumab. / Image: NASA
Pharmaceuticals
1/3 of Pharma Companies Aren’t Ready for Serialization
With the first serialization deadline quickly approaching, more than a third of pharma manufacturers and contract packagers aren’t prepared.
May 24, 2017
Serialization / Image: Cognex
Traceability/Serialization
Packaging and Serialization Experts Partner for Solutions
SGS signs strategic alliance agreement with Kezzler AS as a serialization technology provider for global customers, while Amcor offers packaging experience.
May 22, 2017
SGS signs strategic alliance agreement with Kezzler AS as a serialization technology provider for global customers, while Amcor offers packaging experience.
Cannabis
Cannabis Corner: Mexico, Canada and New Packaging Innovation
The pharmaceutical cannabis sector is expected to reach over $23 billion by 2020 in the U.S. alone, according to ArcView Market Research. New players, from countries to packaging companies, are entering the growing market.
May 18, 2017
Though not related to medical marijuana, Canadian Prime Minister Justin Trudeautook the first steps in legalizing cannabis for recreational purposes with proposed legislation, the Act to Amend the Controlled Drugs and Substances, in April 2017.
Pharmaceuticals
New Research Shows Companies Could Miss Serialization Deadlines
Companies that do embrace the changes and prioritize preparations for the DSCSA and the FMD have a real opportunity to differentiate their offering.
May 15, 2017
Companies that do embrace the changes and prioritize preparations for the DSCSA and the FMD have a real opportunity to differentiate their offering.
Materials
Report Indicates Strong Growth in Continuous Manufacturing
The increasing adoption of continuous technologies by pharmaceutical manufacturing companies and CMOs seeks to address the challenges related to product quality, drug supply and operational costs.
May 11, 2017
The increasing adoption of continuous technologies by pharmaceutical manufacturing companies and CMOs seeks to address the challenges related to product quality, drug supply and operational costs.
Materials
Track-and-Trace Technologies Lead the Security Packaging Market
Diverse ongoing threats, new regulatory requirements for life critical products, and technical evolution will fuel market growth for anti-counterfeiting packaging technologies.
May 10, 2017
Diverse ongoing threats, new regulatory requirements for life critical products, and technical evolution will fuel market growth for anti-counterfeiting packaging technologies.
Pharmaceuticals
THC Could Reverse Brain Decline in Elderly
Microdosing THC increased memory and learning in older mice; clinical trial on humans is next.
May 9, 2017
Marijuana Leaves / Image: Getty
Pharmaceuticals
Pharmaceutical Cargo Thefts on the Decline
Large-scale pharmaceutical cargo thefts descend between 2009 and 2016 as pharma and med device makers take unprecedented steps to secure their products.
May 8, 2017
Large-scale pharmaceutical cargo thefts descend between 2009 and 2016 as pharma and med device makers take unprecedented steps to secure their products.
Medical Device/Packaging
New Website for Med Device Labeling Symbols
The FDA has launched a new website to help the public understand the Use of Symbols in Labeling Final Rule.
May 3, 2017
Medical Device Symbols / Image: EMMA
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