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Search: Page 10

1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Carcinogens in Blood Pressure Drug Went Undetected for 4 Years
FDA officials report that versions of blood pressure-lowering drug valsartan contained trace amounts of a carcinogen.
January 29, 2019
Valsartan / Image: Google
Regulatory
The FDA Threatens to Pull E-Cigs From the Market
The FDA threatened to pull e-cigarettes from shelves if youth smoking rates fail to decline over the next year.
January 23, 2019
Vaper Vaping / Image: UCSF
Supply Chain
Bloomberg: Insulin Flights Booked in Advance of Brexit
Pharmaceutical companies brace for no-deal Brexit to ensure drug supply can reach patients. A lobby groups calls on the government for measures that protect the supply chain.
January 18, 2019
Pharmaceutical companies brace for no-deal Brexit to ensure drug supply can reach patients. A lobby groups calls on the government for measures that protect the supply chain.
Pharmaceuticals
Recall Alert: Michigan Medical Marijuana
In a first for Michigan, a recall has been issued on marijuana, but the state’s seed-to-sale tracking system may save the product.
January 9, 2019
Medicinal Marijuana / Image: Getty Images
Pharmaceuticals
FDA Calls Out Label Issue on E-Cigs Containing ED Drugs
The FDA issued a warning against e-cigarette liquids that contain the main ingredients in two popular male enhancement drugs.
December 17, 2018
E-Liquids contain ED Drugs / Image: CNN
Pharmaceuticals
Infant Ibuprofen Recalled Due to Potency Issues
A popular infant ibuprofen sold at CVS, Family Dollar and Walmart was recalled over concerns that the concentrations may be too high.
December 13, 2018
Infant Ibuprofen / Image: Tris
Pharmaceuticals
Counterfeit Marijuana Packaging is Now a Problem
Cannabis vape cartridge manufacturers in California are beginning to experience the hurdles of counterfeiters.
December 12, 2018
Vape Cartridge / Image: Google
Regulatory
FDA Focuses on Compounded Drug Quality; cGMPs for Outsourcing
Agency updates its compounding priorities plan to address patient safety while revising cGMP draft guidance to make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality.
December 10, 2018
Agency updates its compounding priorities plan to address patient safety while revising cGMP draft guidance to make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality.
Pharmaceuticals
Dog Scared of Loud Noises? Now There’s a Drug for That.
The FDA just approved a drug that helps dogs that suffer from anxiety induced by loud noises.
December 7, 2018
Pexion helps dogs relax. / Image: Getty Images
Traceability/Serialization
French Pharma Company Implements System for EU FMD Compliance
Cloud system enables Cristers to exchange serialization data with supply chain partners and move beyond compliance to improve business practices.
December 6, 2018
French pharma company implements Adents system for EU FMD compliance.
Regulatory
FDA Releases New Guidance for Stored Platelets
Replacing a 2016 guidance, the document includes storage and labeling guidelines as well as reporting instructions for manufacturing and labeling changes.
December 4, 2018
FDA Releases New Guidance for Stored Platelets
Pharmaceuticals
FDA Increases Effort to Fight AIDS
In support of PEPFAR, the agency announced a pilot program with WHO to expedite review of HIV drug applications.
December 4, 2018
Fight Against AIDS / Image: BMC
Pharmaceuticals
FDA Approves Biosimilar, But it Comes with a Severe Label Warning
Truxima is the first FDA-approved biosimilar to Roche’s blockbuster drug for non-Hodgkin’s lymphoma.
December 3, 2018
Celltrion / Image: Kim Hong Ji
Pharmaceuticals
New Drug Uses DNA Rather Than Tumor Type to Treat Cancer
The FDA just approved Loxo Oncology’s Vitrakvi drug that treats cancer in an unconventional way.
November 30, 2018
Cancer Cells in a Tray / Image: Suzanne Plunkett
Regulatory
FDA Aims to Crack Down on Flavored Tobacco Products
FDA Commissioner Scott Gottlieb released a statement on proposed action to reduce flavored tobacco use among teens.
November 29, 2018
Flavored Tobacco Products / Image: ANSRMN
Supply Chain
Reporting Suspicious Orders to the DEA
A DEA Diversion Program Manager highlighted controlled substance order reporting and paperwork to keep on-hand.
November 28, 2018
A DEA Diversion Program Manager highlighted controlled substance order reporting and paperwork to keep on-hand.
Pharmaceuticals
Listen: Podcast on The Fascinating History of Orphan Drugs
Learn how drugs that no pharmaceutical company wanted to make evolved into extremely lucrative products subsidized by the government.
November 22, 2018
Congressman Harry Waxman (left), Sharon Dobkin, Abbey Meyers (center), and Adam Seligman (right). / Image: Abbey Meyers
Nutraceuticals/Dietary
FDA Sends Warning Letters Regarding Tianeptine
Two companies receive notifications from agency for selling products marketed as dietary supplements with known safety issues to patients seeking relief from medical conditions such as opioid abuse disorder.
November 20, 2018
Two companies receive notifications from agency for selling products marketed as dietary supplements with known safety issues to patients seeking relief from medical conditions such as opioid abuse disorder.
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