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1,251 Results
Type: News
Section: Industry News > Regulatory
Materials
LIVE FROM PDA/FDA: Industry Mobilizes to Fight Falsified Medicines
Pfizer representative emphasizes the significance of supply chain security from raw materials and APIs to pharmacies.
September 13, 2016
Materials
LIVE FROM PDA/FDA: Pharmaceutical Inspection Cooperation Scheme Seeks Global Harmonization
PIC/S membership is growing worldwide, yet China and India face regulatory and economic challenges.
September 13, 2016
Pharmaceuticals
LIVE FROM PDA/FDA: FDA Continues Focus on Keeping Public Safe in the Fight Against Counterfeit Drugs
FDA has made strides in identifying vulnerabilities and threats in the supply chain with the implementation of the DSCSA.
September 12, 2016
Supply Chain
Determining the Impact of Packaging and Logistics on the CAR-T Clinical Pipeline
Sept. 14 presentation addresses the systematic study of the impact of logistics decisions on the integrity of critical biomarkers and active clinical product and data generation.
September 12, 2016
Medical Device/Packaging
Mylan Investigated for Antitrust on EpiPen
New York Attorney General launches investigation to see if EpiPen sales contracts contain anticompetitive terms.
September 9, 2016
Pharmaceuticals
Mylan’s Life-Threatening Labeling Error
Patients with urinary issues are mistakenly taking blood pressure-lowering medication due to a potentially lethal drug swap mix-up.
September 6, 2016
Pharmaceuticals
University Research Takes New Approach to Battle Counterfeits
Researchers at the Universities of Luxembourg, Ljubljana and Vienna collaborate on non-biometric physical tokens that can’t be cloned or copied.
August 29, 2016
Pharmaceuticals
Medical Tracking Solutions Selects Logi Analytics
Logi software will be embedded into iTraycer, the MTS software, to enhance the customer’s ability to mine data for information for real-time decision-making.
August 26, 2016
Regulatory
FDA Revises Guidance on Dietary Supplements
The FDA revamps efforts in the fight against shaky medical claims and potentially harmful new ingredients in dietary supplements.
August 25, 2016
Materials
Open-SCS Reports Track-and-Trace Model Progress
Focus on standardizing serialization data exchanges across the healthcare supply chain. Next workshop is scheduled for Sept. 2016 in Germany.
August 15, 2016
Regulatory
DEA Denies Two Petitions to Reschedule Marijuana under the Controlled Substances Act (CSA)
For now, marijuana remains a schedule I controlled substance in the U.S.
August 11, 2016
Medical Device/Packaging
FDA Issues Updated Medical Device Recommendations
The goal: Help manufacturers determine when they must notify the agency about modifications to devices already on the market. Separate guidance applies to software devices.
August 5, 2016
Materials
BRC Publishes Revised Global Standard for Storage and Distribution
BRC Global Standards published its third issue of BRC Global Standard for Storage and Distribution on Aug. 1, with audits against Issue 3 to begin Feb. 1, 2017.
August 5, 2016
Pharmaceuticals
Cephalon Reaches $125M Settlement with U.S. States
Cephalon reaches its second massive settlement in just over a year for unlawfully protecting their Provigil patent.
August 5, 2016
Medical Device/Packaging
HealthPack 2017 Heads to Denver
Aug. 26 is the call for presentations deadline for the March 7 to 9, 2017 event that analyzes trends in medical device packaging.
August 1, 2016
Materials
Predicting the Pharmaceutical Packaging Market Through 2026
Visiongain report cites increasing demand for blister packaging, anti-counterfeiting technology, online printing and R&D investments in certain therapeutic areas as growth factors in pharmaceutical packaging.
July 28, 2016
Pharmaceuticals
Child-Resistant Closure Requirement Failure Causes Recall
Novel Laboratories recalls Zolpidem Tartrate blister packs; U.S. CPSC says it poses poisoning risk if swallowed by children.
July 27, 2016
Medical Device/Packaging
FDA Releases UDI Draft Guidance
Agency welcomes comments and suggestions to draft document within 60 days of publication in the Federal Register.
July 25, 2016
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