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Search: Page 12

1,251 Results
Type: News
Section: Industry News > Regulatory
Traceability/Serialization
Grandfathered Products? Keep Your Records!
How will trading partners know which products are grandfathered after Nov. 27?
October 8, 2018
How will trading partners know which products are grandfathered after Nov. 27?
Regulatory
Researchers Want Magic Mushrooms Reclassified to Schedule IV
Scientists at Johns Hopkins believe psilocybin should be classified as a schedule IV drug to facilitate its path to the clinic.
October 5, 2018
Mushrooms / Image: Getty Images
Traceability/Serialization
ICYMI: FDA Released Three DSCSA-Related Guidances
New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.
October 4, 2018
New draft and finalized guidance docs were recently released regarding product identifiers and grandfathering.
Medical Device/Packaging
FDA Eases Regulations on Female Condoms
The FDA reclassified single-use female condoms from Class III to Class II, lowering the regulatory burden for makers of the contraceptive devices.
October 4, 2018
FDA Eases Regulations on Female Condoms
Regulatory
FDA Modernizes its Approach to Clinical Trials for Drugs and Biologics
Agency issues two new draft guidances in an effort to make clinical trials more efficient while lowering costs and strengthening its ‘gold standard for safety and efficacy.’
September 28, 2018
Agency issues two new draft guidances in an effort to make clinical trials more efficient while lowering costs and strengthening its ‘gold standard for safety and efficacy.’
Pharmaceuticals
Justice Dept. Okays $52B Merger of Cigna and Express Scripts
Federal officials have approved the vertical merger between one of the largest health insurers and a key pharmacy benefit manager.
September 26, 2018
Merger Okayed / Image: Julio Cortez
Supply Chain
FDA Takes Renewed Aim at E-Cig Marketing
Some brand owners who received warning letters have 60 days to come up with plans to address teen use of their products. Distribution is also under the microscope.
September 19, 2018
Gottlieb says the FDA issued 12 warning letters to other companies that continue to advertise and sell the violative products.
Pharmaceuticals
OxyContin Creator Sued for Creating Opioid Epidemic
Colorado’s attorney general is suing Purdue Pharma for its “significant role in causing the opioid epidemic.”
September 17, 2018
Oxycontin
Traceability/Serialization
Recipharm Connects to European Hub for Serialization Compliance
Recipharm’s three-year serialization program began in January 2016 and involves a 40-million-euro investment.
September 14, 2018
Recipharm’s three-year serialization program began in January 2016 and involves a 40-million-euro investment.
Pharmaceuticals
New Bill Aims to Legalize Medical Marijuana for Military Vets
A new senate bill could legalize medical marijuana for veterans of the military to treat pain and curb opioid abuse.
September 14, 2018
Medical Marijuana / Image: Forbes
Regulatory
Hurricane Florence: Tips on How to Protect Packaged Foods and Medications
FDA, CDC offer information to safeguard foods and drugs—such as insulin—during power outages, flooding, and severe weather conditions.
September 13, 2018
FDA, CDC offer information to safeguard foods and drugs—such as insulin—during power outages, flooding, and severe weather conditions.
Pharmaceuticals
Careful, Your Diabetes Meds Could Cause A Genital-Eating Infection
The FDA is recalling a diabetes medication that is causing a rare and deadly flesh-eating condition that concentrates on the genital area.
September 10, 2018
Flesh-Eating Bacteria
Pharmaceuticals
Labeling Issue Prompts Blood Pressure Medicine Recall
Accord Healthcare recalled bottles labeled for hydrochlorothiazide that actually contained spironolactone, according to the FDA.
September 4, 2018
Recalled Lot
Pharmaceuticals
Pfizer Recalls Bubble Gum-Flavored Children’s Advil
Mismatched dosage cups and overdose concerns have prompted a voluntary recall of Children’s Advil Suspension.
September 3, 2018
Recalled Children's Advil / Image: Arizona's Family
Pharmaceuticals
Potentially Life-Threatening Issues Lead to Voluntary Medicine Recalls
A labeling mix-up, incorrect dosage cup markings, and possible microbial contamination give patients plenty of reasons to give pause.
August 29, 2018
A labeling mix-up, incorrect dosage cup markings, and possible microbial contamination give patients plenty of reasons to give pause.
Medical Device/Packaging
FDA Extends EpiPen Expiration Dates in Response to Regional Shortages
The FDA has extended the expiration dates of EpiPens to overcome shortages; some could be effective up to four months past their expiration date.
August 28, 2018
EpiPen Pack / Image: Rich Pedroncelli
Pharmaceuticals
VRS Network Test Results Set for October Release
The Healthcare Distribution Alliance will provide updates to its Verification Router Service during its Oct. 17-19 seminar at the Renaissance Washington, DC Downtown hotel.
August 27, 2018
A VRS could be used to manage acceptance, formatting and delivery of requests/responses to support DSCSA verification requirements (Credit: HDA)
Regulatory
EMA Expects 30% Staff Loss
As a result of Brexit, the EMA is moving to Amsterdam and the agency is temporarily scaling back and suspending certain activities to cope.
August 27, 2018
By October 1, the European Medicines Agency (EMA) plans to start the next phase in its business continuity plan.
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