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1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Now Thereā€™s a Drug for Postpartum Depression
The FDA just approved the first drug to treat postpartum depression, but it requires a stay in a medical center.
March 25, 2019
Postpartum Depression Drug / Image: Getty
Pharmaceuticals
Defective Packaging Causes Birth Control Recall
Four lots of Ethinyl Estradiol USP pills were recalled due to defective blisters, empty blisters, and incorrect tablet placement.
March 14, 2019
Birth Control Blister Pack / Image: TribLive
Adherence/Delivery
Opioid Crisis: FDA to Adjust Pill Packaging and Dosing
In an effort to combat opioid abuse, the FDA plans new dosage forms and small-quantity packaging.
March 8, 2019
Pharmaceuticals
Report Predicts Soaring Global Track-and-Trace Market
Barcodes and RFID help the pharmaceutical industry ensure supply chain security and authenticate the life history of products.
March 7, 2019
Barcodes and RFID help the pharmaceutical industry ensure supply chain security and authenticate the life history of products.
Regulatory
FDAā€™s Scott Gottlieb Resigns
According to at least one published report, his decision will be effective in ā€˜about a month.ā€™
March 5, 2019
FDA’s Scott Gottlieb Resigns: According to at least one published report, his decision will be effective in ‘about a month.’
Medical Device/Packaging
The FDA Doesnā€™t Want Robots Performing Breast Cancer Surgery
New data suggests the use of devices for cancers that affect women are linked to ā€œdiminished long-term survival.ā€
March 4, 2019
Robotic Surgery / Image: VCG
Traceability/Serialization
Pharma Dispensers Need Linear Barcodes
A director for the National Association of Chain Drug Stores discussed practical aspects of serialization, including barcode readability issues.
March 1, 2019
Christopher Smith, Director of Federal Public Policy at the National Association of Chain Drug Stores (NACDS), when he addressed the 11th Pharma Packaging and Labeling East Coast 2019 conference.
Pharmaceuticals
Counterfeit Pills Containing Fentanyl Found in 46 States
Executive Director of the Partnership for Safe Medicines notes the risk of importing counterfeit drugs.
March 1, 2019
Fentanyl / Image: WBUR
Nutraceuticals/Dietary
Baby Gripe Water Recalled Due to Choking Hazard
The FDA recalled DG Baby Gripe Water sold at Dollar General stores because an ā€œundissolved ingredientā€ creates a choking hazard.
February 22, 2019
Gripe Water / Image: KATU
Pharmaceuticals
FDA Says Not to Buy Young Blood Transfusions
The FDA officially says there is no clinical evidence that young blood transfusions do anything, and the procedure could be dangerous.
February 20, 2019
Young Blood / Image: Cory Zapatka
Pharmaceuticals
Supply Chain Issues Call for Track-and-Trace Technologies
New report forecasts nearly 19% CAGR for these solutions to improve security and drug traceability.
February 19, 2019
New report forecasts nearly 19% CAGR for these solutions to improve security and drug traceability.
Regulatory
First Warning Letter Issued Under DSCSA
FDA sends McKesson a warning, highlighting issues with illegitimate product notification, quarantining and record-keeping.
February 12, 2019
FDA sends McKesson a warning, highlighting issues with illegitimate product notification, quarantining and record-keeping.
Pharmaceuticals
Environmental Reporting Gains Priority for Pharmaceutical Industry
During Pharmapack Europe 2019, Lorax Compliance COO Michelle Carvell urged the pharmaceutical industry to prioritize its environmental reporting obligations for packaging or risk high financial penalties.
February 12, 2019
During Pharmapack Europe 2019, Lorax Compliance COO Michelle Carvell urged the pharmaceutical industry to prioritize its environmental reporting obligations for packaging or risk high financial penalties.
Regulatory
Feds Seize Record Amount of Fentanyl
Customs and Border Protection discovered 254 lbs of fentanyl hidden among cucumbers in a truck trailer.
February 6, 2019
Fentanyl Bust / Image: NBC News
Pharmaceuticals
Recall Alert: Infant Liquid Ibuprofen, Part II
The recall of an infant pain reliever is snowballing due to concerns of dangerously high concentrations of the medication.
February 5, 2019
Infant Ibuprofen / Tril-Pharma
Regulatory
Pharma Analyst Assesses Impact of Looming Government Shutdown
FDA employees, drug developers, and patients have much to lose if drug approvals are stalled by months due to another shutdown.
February 1, 2019
FDA employees, drug developers, and patients have much to lose if drug approvals are stalled by months due to another shutdown.
Regulatory
FDA Plans to Advance Complex Generics
Agency pushes policies to promote generic competition for these drugs that by the nature of their formulation, delivery systems, or ingredient complexities, are more difficult to ā€œgenericizeā€ and often face less competition.
January 31, 2019
Agency pushes policies to promote generic competition for these drugs that by the nature of their formulation, delivery systems, or ingredient complexities, are more difficult to “genericize” and often face less competition.
Cannabis
Vape Cartridges with Cartoon Packaging Seized in Kansas
Deputies in Sedgwick County seized THC-infused vape cartridges intended for medical use that were smuggled from California.
January 30, 2019
Seized Vape Packaging / Image: Wichita Eagle
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