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1,882 Results
Section: Industry News > Regulatory
Packaging/Filling
5 Tips on Remote Auditing Contract Organizations
Switching to hybrid or virtual audits? Check out these tips for a smoother transition. Additionally, PDA is holding a remote audit and inspection workshop Apr. 8.
March 15, 2021
Regulatory
PDA Post-Approval Change Issues and Impacts Survey
PDA
This comprehensive survey includes data on the challenges presented by inconsistencies in how regulators treat post-approval changes and respondents’ experience with specific regulators.
February 24, 2021
Regulatory
3 Key Takeaways from the EMA Clinical Trial Guidance Update
New version addresses remote source data verification amid the COVID-19 pandemic.
February 18, 2021
Temp Control/Cold Chain
How FDA Food Supply Data Supports COVID-19 Vaccine Distribution
In the latest FDA Voices post, Dr. Stephen Hahn and Frank Yiannas, M.P.H. discuss how the new data analysis tool, 21 FORWARD, is helping food and agriculture workers receive vaccines.
January 20, 2021
Traceability/Serialization
Serialization 101
Fraud is a serious issue for drug manufacturing, and pharmaceutical and medical device regulations using serialization have been mandated to defend against counterfeiting.
January 13, 2021
Market Trends
Quotables and By the Numbers to Start the Year
Quotes and stats on clinical trial demographics, modes of transportation, the personalized medicine market, and more...
January 7, 2021
Traceability/Serialization
Counting Down the Top 10 Articles of 2020 - #8: CDMO Speeds Line with L4 Serialization
Join us as we look back at the most-read Healthcare Packaging stories of 2020. At #8, we cover one CDMO’s implementation of an open-source serialization system.
December 23, 2020
Robotics/Automation
Serialization Continues to Impact Pharma Automation Investments
Automation and IoT are on trend, as the industry continues to meet serialization regulations.
December 10, 2020
Traceability/Serialization
FDA Dec. Meeting: Drug Supply Chain Security Act Pilot Project Program
FDA
FDA will host a virtual public meeting Dec. 8 and 9, 2020.
November 25, 2020
Regulatory
Govzilla Announces New Customer Platform and Company Name Change to Redica Systems
November 22, 2020
Adherence/Delivery
COVID-19 Vaccine: HHS Partnering with Major Pharmacy Chains
The partnership will cover approximately 60% of pharmacies throughout the U.S. states, D.C, Puerto Rico, and the U.S. Virgin Islands.
November 16, 2020
Pharmaceuticals
Growth of Pharmaceutical Packaging Equipment Market Driven by OTCs, Generics, and More
The global pharmaceutical packaging equipment market size is projected to increase at a CAGR of 7.4% from $7.3 billion in 2020 to $10.4 billion by 2025.
November 5, 2020
Supply Chain
Saleable Returns Verification Delayed to 2023
Additional three-year delay: FDA guidance says distributors will not be required to verify the product identifier of returned drugs before resale until Nov. 27, 2023.
October 23, 2020
Cannabis
Cannabis Policy Vote May Happen by End of 2020
The MORE Act would be historic in that it would remove cannabis from the Controlled Substances Act, opening a path for regulations to follow.
October 1, 2020
Industries
Gerresheimer Laboratory and Regulatory Services for Biotech Customers
Gx Biological Solutions offers enhanced services for pharmaceutical primary packaging in the US and in Europe.
September 28, 2020
Traceability/Serialization
Serialization Partnership Announced to Fight Against Counterfeit Drugs
Syntegon
Track-and-trace provider advanco launches strategic serialization partnership with leading pharmaceutical packaging company Syntegon.
September 21, 2020
Regulatory
Live from PDA/FDA: FDA Considers Incentivizing Quality Management Maturity (QMM)
The Agency is soliciting feedback from manufacturers on assessing and rewarding QMM through Oct. 2020. Reduced audit frequency may one day be an incentive for high performers.
September 15, 2020
Pharmaceuticals
CPhI Festival of Pharma 2020 in October
Former FDA commissioner Dr. Scott Gottlieb to address industry on sustainable innovation at the two-week long event. Sessions will cover affordable medicines, supply change resiliency, AI, Vaccine production, and more.
September 9, 2020
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