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1,251 Results
Type: News
Section: Industry News > Regulatory
Materials
Serialization Remains a Disruptive, Expensive Initiative
The future role of the pharmacy, package design and new EU regulations all challenge the pharmaceutical industry as it addresses serialization and track and trace.
February 7, 2017
Pharmaceuticals
FDA Sends 8 International Warning Letters
FDA shows signs of international work by sending warning letters to five medical device companies and three pharma firms.
February 6, 2017
Materials
Live from Pharmapack: Protecting Patients Against Falsified Medicines
Breaking news: Regulations such as EU 2016/161, which has to be implemented by February 9, 2019, require innovative solutions to protect patients against falsified medicines.
February 1, 2017
Pharmaceuticals
Trump to Pharma: Lower Prices & Fewer Regulations
President Trump met with Big Pharma players to discuss lowering prices and bringing drug manufacturing back to the U.S.
February 1, 2017
Materials
Predicting the Future of the Global Pharmaceutical Packaging Market
Expansion of generic market, technological advancement, and strict governmental regulations for conventional packaging are major factors that drive the market growth.
January 31, 2017
Nutraceuticals/Dietary
Hyland’s Refuses to Recall their Toxic Baby Product
The FDA has identified lethal doses of belladonna in Hyland’s teething products, but the company refuses to recall products.
January 31, 2017
Pharmaceuticals
Doctor Convicted for Criminal Sale of Opioids
A Long Island “drug dealer in a white coat” who sold prescriptions for narcotics faces up to 15 years in prison.
January 30, 2017
Pharmaceuticals
Ropack Provides International Serialization Hub
Contract development and manufacturing company selects cloud-based system to assist its 130+ pharma customers as they prepare for DSCSA deadline.
January 26, 2017
Pharmaceuticals
Systech Announces Program for Rapid DSCSA Compliance
Ninety-day compliance program enables U.S. pharmaceutical companies that distribute prescription drugs within the U.S. to meet November 2017 DSCSA deadline.
January 26, 2017
Materials
Best Practices for Global Commercial Supply in an Evolving Market
PCI’s Feb. 9 serialization seminar to focus on establishing and developing serialization regulations that vary from country to country.
January 26, 2017
Regulatory
ASTM International Looks At Potential Cannabis Standards, Committee
The green revolution is happening all around us. Are ASTM standards the next step in full-scale public and regulatory acceptance?
January 23, 2017
Materials
FDA Issues Regs on Combination Products
Explains final rule on CGMP requirements for combination products for which the agency issued a draft document in Jan. 2015. No new requirements were established. Postmarketing safety report final rule also provided.
January 23, 2017
Pharmaceuticals
Spasm Medicine Goes From $40 to $34,000
Mallinckrodt will pay $100 million settlement after raising price of infantile spasm medication 85,000%.
January 23, 2017
Medical Device/Packaging
FDA Announces Draft Guidances on Medical Product Communications
Guidances provide agency recommendations on labeling, as well as unapproved uses of approved or cleared medical products. Commissioner Robert Califf, M.D., notes reopened comment period extending to April 19, 2017.
January 20, 2017
Regulatory
FDA Gets Patent for Counterfeit Drug Detector
The US Food and Drug Administration’s CD-3, a handheld fake drug detection device, has been awarded a US patent.
January 19, 2017
Traceability/Serialization
HDA to Host DSCSA 2023 Webinar
The Feb. 14 webinar will focus on DSCSA 2023 provisions to facilitate unit-level traceability across the U.S. supply chain.
January 18, 2017
Pharmaceuticals
Readying for Serialization, Track-and-Trace Deadlines
In anticipation of the Nov. 27, 2017 DSCSA deadline, software provider Adents beefs up its team to accommodate pharmaceutical demand.
January 17, 2017
Pharmaceuticals
Antares Vision to Host Next Meeting of Open-SCS Group in Brescia, Italy
At the January event, the Open Serialization Communication Standard Group will continue to work on a universal communication standard for data generated by serialization implementation.
January 11, 2017
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