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1,251 Results
Type: News
Section: Industry News > Regulatory
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Antares Vision Group to Demo New Mini Manual Aggregation Station for Small- to Mid-Sized Production, Among Other Recently Introduced Traceability & Inspection Solutions
Antares Vision Group
See it at Booths #SL-6502 and #C-3938! Company also will demo “Track My Way,” a traceability platform opening dialogue between various supply chain stakeholders, including consumers.
September 22, 2021
Medical Device/Packaging
Manufacturers To Highlight Medaccred Accreditation At Medical Design And Manufacturing (West) 2021
August 11, 2021
Regulatory
FDA Final Guidance: Form and Content of the Unique Device Identifier (UDI)
FDA
The document is intended to assist labelers and FDA-accredited issuing agencies in complying with unique device identifier (UDI) labeling requirements, including by clarifying FDA’s interpretation of certain requirements under 21 CFR 801.40.
July 10, 2021
Regulatory
Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages
FDA
Guidance for industry and FDA staff. Comments can be submitted.
May 21, 2021
Materials
ASTM International Honors PAXXUS CEO with Award of Merit
PAXXUS
Dhuanne Dodrill, CEO of PAXXUS, has been honored by ASTM International for her efforts in medical packaging.
April 19, 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
Govzilla Announces New Customer Platform and Company Name Change to Redica Systems
November 22, 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
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
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
Aseptic/Sterile
Aptar Requests U.S. FDA Emergency Use Authorization for N95 Filtering Facepiece Respirator Decontamination with ActivShield(TM)
Aptar
The company is working to provide approximately four million ActivShield strips per week and is working to expand its production capacity with the intent to deliver ten million per week by the end of April.
April 17, 2020
Pharmaceuticals
FDA Approves Activ-Blister™ Packaging for HIV Drug
The FDA has approved AptarGroup’s packaging solution for oral solid dose HIV prevention medicine.
October 25, 2019
Nutraceuticals/Dietary
FDA Finds Asbestos in Baby Powder, Recall Ensues
Johnson & Johnson recalled thousands bottles of their famous baby powder after the FDA found trace amounts of asbestos.
October 24, 2019
Pharmaceuticals
FDA Approves New Acute Migraine Drug
Eli Lilly’s new drug Reyvow relieves pain, nausea, and light sensitivity in within two hours of ingestion.
October 14, 2019
Pharmaceuticals
FDA Approves HIV Drug, But Only for Men
Gilead Sciences only tested Descovy on men and transgender women, and the approval explicitly excludes cisgender women.
October 10, 2019
Traceability/Serialization
How QR Codes Can Help Drug Makers Streamline Recalls
Concerns about a carcinogenic impurity have prompted recalls of Zantac and generic versions of the popular heartburn medication. Smart labeling technology could speed and clarify alerts to consumers and also help drug companies reduce scrapped lots.
October 9, 2019
Pharmaceuticals
Mislabeling Leads to 17 Cases of Infant “Werewolf Syndrome”
Children in Spain have developed hypertrichosis after a reflux drug was contaminated with alopecia treatment.
October 9, 2019
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