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1,251 Results
Type: News
Section: Industry News > Regulatory
Medical Device/Packaging
New Bill Seeks Better Cybersecurity for Medical Devices
A new bill brings together regulators, manufacturers, and providers to address cybersecurity vulnerabilities in medical devices.
October 16, 2017
Cyberhacked / Image: FiercePharma
Pharmaceuticals
Praxis Packaging Ready for DSCSA Deadline
With the DSCSA enforcement delay, manufacturers and contract packagers such as Praxis are refining their serialization programs.
October 13, 2017
Praxis Packaging is ready to meet the DSCSA deadline. Seen here is a Praxis cleanroom.
Pharmaceuticals
Senator Seeks to Close Tribal Patent Loophole
Senator Claire McCaskill has introduced a bill aimed at ending the practice of exploiting tribal sovereign immunity to protect patents.
October 12, 2017
Senator McCaskill isn't amused. / Image: FiercePharma
Pharmaceuticals
FDA’s Drug Approvals on Track to Double Over Last Year’s Pace
Obamacare repeals have repeatedly failed, but the FDA is accelerating its operations to approve drugs at an unprecedented rate.
October 10, 2017
FDA Scott Commissioner Gottlieb / Image: Zach Gibson/Getty Images
Pharmaceuticals
Reaching an ‘Inflection Point’ in Pharmaceutical Manufacturing
FDA issues guidance to advance novel treatment therapies that often require advanced manufacturing technology. Could it help lower pharma manufacturing costs?
October 3, 2017
FDA issues guidance to advance novel treatment therapies that often require advanced manufacturing technology. Could it help lower pharma manufacturing costs?
Pharmaceuticals
Open-SCS Group Showcases Packaging Serialization Standard
At PACK EXPO Las Vegas, the organization launched a pilot to test initial communications among global pharma industry group members. The release of a validated standard is projected by Nov. 2017.
October 2, 2017
At PACK EXPO Las Vegas, the organization launched a pilot to test initial communications among global pharma industry group members. The release of a validated standard is projected by Nov. 2017.
Pharmaceuticals
FDA Cracks Down on Websites Illegally Selling Opioids
The U.S. Food and Drug Administration is going after over 500 rogue websites selling unapproved versions of prescription medications.
September 29, 2017
Website seizure notice / From: buyklonopin.com
Regulatory
Operation Pangea X Takes Action Against Illegal Online Pharmacies
FDA partners with international regulatory and law enforcement agencies to act against more than 500 websites selling illegal prescription drugs.
September 25, 2017
More than US$51 million worth of potentially dangerous medicines were seized globally during Operation Pangea X. (Interpol photo.)
Traceability/Serialization
Spotted at Healthcare Packaging EXPO: AR Glasses
On display at booth N-219, Microsoft and Adents team up to create augmented reality glasses as a control tool for serialized pharma products.
September 25, 2017
Adents Prodigi
Cannabis
Serialization and Medical Marijuana Take Center Stage
Two special events at Healthcare Packaging EXPO/PACK EXPO Las Vegas provide exclusive perspectives on two of the most pressing issues in the life sciences arena.
September 19, 2017
Healthcare Packaging EXPO logo
Regulatory
PDA/FDA: Trends in Compliance and Enforcement
FDA’s Office of Manufacturing Quality talks about 2017’s enforcement action numbers, and the spike in warning letters.
September 14, 2017
Of the 119 enforcement actions OMQ’s taken through September 1, 2017, 45 have been warning letters.
Pharmaceuticals
Good News: FDA Approves Gene Therapy for Cancer. Bad News: It Costs $475k
The FDA has approved Novartis’ “first gene therapy” in the U.S. designed to treat blood and bone marrow cancer in children and young adults.
September 14, 2017
Novartis / Image: Pharma Phorum
Pharmaceuticals
Live from PDA/FDA: 5 Key Landscape Takeaways
From packaging and manufacturing to higher public-sector salaries, how are FDA and industry rising to meet cell- and tissue-based product challenges?
September 11, 2017
It’s one (amazing) thing to create a cell-based therapy or device in a specialized research lab, but it’s entirely another to create repeatable, standardized manufacturing on a larger scale where cell growth and manipulation are involved. Source: NIBIB
Traceability/Serialization
FDA: New Supply Chain Draft Guidance
With public meetings on security and data exchange, FDA releases guidance that helps companies “define the relationship” with trading partners. The agency is soliciting comments.
August 30, 2017
New FDA guidance includes sections that discuss repackagers, WDDs, 3PLs and dispensers, with subsections for partners such as brokers and common carriers.
Regulatory
Pig Organ Transplants on the Horizon
Pending approval from the Chinese government, pig-to-human organ transplants could greatly reduce the waiting period for patients in need.
August 30, 2017
Pigs are ideal for xenotransplantation. / Image: W. W. Norton & Company
Pharmaceuticals
FDA Designates Ecstasy a “Breakthrough Therapy” for PTSD
The U.S. Food and Drug Administration’s classification of MDMA as a “breakthrough therapy” could lead to faster approval.
August 28, 2017
MDMA is better known as the party drug ecstasy. / Image: Science Mag
Regulatory
Probiotic Treats Peanut Allergy for up to 4 Years
A probiotic containing a peanut protein effectively treats peanut allergies up to four years after it's administered.
August 21, 2017
Peanut Allergy
Traceability/Serialization
Pharma Supply Chain: Comments Due Sep 18!
The FDA is soliciting public feedback before the establishment of a pilot program under the DSCSA. Get your comments in soon.
August 17, 2017
The FDA is soliciting public feedback before the establishment of a pilot program under the DSCSA. Get your comments in soon.
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