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1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Goldman Sachs Leads $50M+ TraceLink Round
TraceLink closes Series C financing to help companies comply with country-specific track-and-trace requirements.
December 6, 2016
TraceLink / Photo: TraceLink
Medical Device/Packaging
Medtronic Neurovascular Recall
Medtronic recalls nearly 4,000 lots of four different products used to treat cerebral aneurisms.
December 5, 2016
Alligator Retrieval Device / Photo: Covidien
Medical Device/Packaging
Apple Talks Cardiac Devices with FDA
Emails obtained by MobiHealthNews reveal Apple is in the process of developing medical equipment with the FDA.
December 2, 2016
Apple Watch / Image: Redmond Pie
Nutraceuticals/Dietary
More Trouble for Homeopathic Treatments
Potentially dangerous levels of belladonna leads to voluntary recall by Raritan Pharmaceuticals. FTC issues enforcement policy statement on marketing claims for OTC homeopathic drugs. The extract can be fatal when consumed in large doses.
December 1, 2016
This photo shows examples of homeopathic medicine.
Supply Chain
The Benefits of Serialization Experience from Other Markets
Familiar with the complexities, suppliers from the financial and healthcare communication markets offer decades of track and trace experience to pharmaceutical manufacturers.
December 1, 2016
As serialization efforts transition from planning to implementation, suppliers must be able to integrate, validate and troubleshoot lines by November 2017.
Medical Device/Packaging
Genalyte Raises $36M for One-Drop Blood Test
Lab-on-a-chip technology can run 120 blood tests from a single drop of blood in just 15 minutes.
November 28, 2016
Genalyte's test produces results in 15 minutes.
Regulatory
Teva Expects to Pay $500M+ for Bribery Allegations
Teva in “advanced discussions” to settle DOJ and SEC accusations of bribery in foreign countries.
November 23, 2016
Teva Bribery Allegations
Medical Device/Packaging
HealthPack 2017 to Address Hot-Button Medical Device Issues and Trends
Speakers from Cardinal Health, J&J and DePuy Synthes, nurses and technicians panel, and a live audience polling session highlight March 7-9, 2017 program in Denver.
November 22, 2016
The nurses and technicians panel is an annual highlight of HealthPack. Here, thee professionals from a recent show are shown reviewing medical device packages for examination.
Nutraceuticals/Dietary
GNC Women’s Dietary Supplement Recalled
Bad news for lactose intolerant women: your dietary supplement may accidentally contain milk.
November 22, 2016
GNC Women's Ultra Mega Time Release / Photo: GNC
Regulatory
Statement on FDA’s Final Guidance Delay for Lab-Developed Tests
Senate health committee Chairman Lamar Alexander weighs in on FDA pushing final guidance to next administration.
November 21, 2016
Chairman Alexander / Photo: Getty Images
Medical Device/Packaging
Opioid Overdose Device Recalled
Teleflex voluntarily recalls device used to administer medication that reverses the effects of opioid overdose.
November 18, 2016
LMA MAD Intranasal Mucosal Atomization Device / Photo: Teleflex
Regulatory
How Might Trump’s Win Affect the Pharma Industry?
Speculations swirl about what the election results mean in terms of regulations and finance in pharmaceuticals and med devices.
November 16, 2016
Though some Americans have pushed for the option to import cheaper drugs from other countries, the FDA has expressed concerns about the potential for entry of counterfeit drugs.
Pharmaceuticals
Next Generation Blood Collection and Separation Technology Receives FDA 510(k) Clearance
A new BD plasma blood collection tube is now commercially available to improve laboratory efficiency.
November 15, 2016
When stretched, channels are created around the separator allowing blood cells to sediment out of the plasma throughout the centrifugation process.
Pharmaceuticals
HDA Surveys Show Promising DSCSA-Ready Results
Pilot Study for Saleable Returns recommends two scenarios to help with compliance. Meanwhile, majority of manufacturers say distributors will start to receive serialized products before the Nov. 27, 2017 DSCSA deadline.
November 14, 2016
Pharmaceuticals
1.3 Million Birth Control Pills Recalled
Endo recalls 162 lots of subpotent birth control pills manufactured by Patheon.
November 14, 2016
Gildess Packaging / Image: FiercePharma
Pharmaceuticals
Bell and Howell Helping Pharmaceutical Companies Navigate DSCSA
Company hosting Southeast Traceability & Serialization Forum Nov. 17. Agenda includes updates from Excellis Health and the Healthcare Distributor Alliance.
November 11, 2016
Company hosting Southeast Traceability & Serialization Forum Nov. 17. Agenda includes updates from Excellis Health and the Healthcare Distributor Alliance.
Regulatory
IGBressan’s Magic Folding Boxes
Italy’s IGBressan has three new and unique box designs for child resistance, tamper evidence and recreational marijuana.
November 11, 2016
Tamper Evident Box (left) and Child Resistant Box (right)
Pharmaceuticals
Panel Offers Advice to Implement Pharmaceutical Serialization
Meeting the November 2017 compliance deadline needs top management commitment and involve packaging line operators.
November 10, 2016
Practical advice for serialization implementation
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