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Search: Page 41

1,251 Results
Type: News
Section: Industry News > Regulatory
Pharmaceuticals
Assessing options in anti-counterfeiting
Spectroscopy can help distinguish counterfeits by testing a packaging or pharmaceutical product with an instrument that graphs responses to light and generates a match or no-match message.
November 4, 2014
A view of the main concourse area during PACK EXPO International Nov. 4 in Chicago.
Medical Device/Packaging
Richard-Allan Scientific recalls 10% neutral buffered Formalin
The impacted products contained less Formalin content than stated.
November 1, 2014
Traceability/Serialization
Animal health medications benefit from serialization technology
Serialization technology protects global pharmaceutical and biotech maker protect its flea-and-tick medications.
October 30, 2014
Serialization technology protects global pharmaceutical and biotech maker protect its flea-and-tick medications.
Regulatory
Baxter Voluntarily Recalls INTRAVIA Containers
The recall was prompted after complaints about particulate matter found inside the fluid path.
October 26, 2014
Medical Device/Packaging
FDA helps small medical device companies innovate quicker
National Medical Device Curriculum addresses learning needs; aims to advance medical device development through a case-study approach.
October 23, 2014
National Medical Device Curriculum addresses learning needs; aims to advance medical device development through a case-study approach.
Regulatory
Packaging Mix-Up Prompts Recall of Assured Brand Naproxen Sodium Tablets
Ibuprofen bottles were placed in the Naproxen Sodium boxes instead of the intended product.
October 23, 2014
Regulatory
FDA-Banned Drugs Found in Supplements Sold to Consumers
Regulations come under fire, as FDA admits there is a 'challenge' to enforcement.
October 23, 2014
Pharmaceuticals
Octapharma adds track-and-trace serialization aggregation
Developer, producer, and seller of human proteins requires a flexible and validated system for marking, identifying, and tracking its products.
October 21, 2014
Octapharma's Vienna site will employ Werum's PAS-X Track & Trace system.
Materials
FDA announcements touch upon healthcare packaging and regulatory issues
Agency addresses increasing complexity of FDA’s mandate, globalization in the supply chain, and the trend of rapid scientific innovation.
October 20, 2014
Agency addresses increasing complexity of FDA’s mandate, globalization in the supply chain, and the trend of rapid scientific innovation.
Regulatory
Roche's Ebola Virus Test Could Be Fast-Tracked by FDA
Laboratories who want to handle Ebola samples would have to meet specific safety requirements.
October 16, 2014
Medical Device/Packaging
FDA announces medical device cybersecurity guidance
Agency to hold Oct. 21 and 22 public workshop on collaborative approaches for medical device and healthcare cybersecurity.
October 13, 2014
Agency to hold Oct. 21 and 22 public workshop on collaborative approaches for medical device and healthcare cybersecurity.
Pharmaceuticals
Amgen's Next-Gen manufacturing
New plant in Singapore uses disposable, single-use processing components designed to eliminate the need for cleaning and sterilization, and the validation that goes with it.
October 6, 2014
Next-Gen manufacturing benefits Amgen. This photo is for illustrative purposes only.
Supply Chain
Watch for expanded Chapter topics
Chapter Good Distribution Practices expanding scope to include APIs, excipients, dietary supplements, and more.
October 1, 2014
This is an image of a refrigerated truck, for illustrative purposes.
Pharmaceuticals
FDASIA strengthens agency’s authority
Reviewing provisions of the legislation that impact drug product inspections.
September 26, 2014
Reviewing provisions of the legislation that impact drug product inspections.
Labeling/Printing
Pharmaceutical packaging innovation advances quality, speed, and efficiency
Latest technologies and educational opportunities showcased at Pharma EXPO.
September 25, 2014
Materials
Changes made to EU Guidelines for GMPs
Chapter 5, sections 17 to 21 revisions provide guidance that aims to help prevent cross-contamination and benefit supply chain traceability.
September 24, 2014
Pharmaceuticals
Guideline delineates how to implement GS1 standards
Document provides intelligence to support pharmaceutical lot-level management and future item-level traceability requirements
September 17, 2014
GS1 US published a guideline on how to implement GS1 Standards to support 2013 DSCSA. Photo is for illustration purposes only
Materials
PDA developing Technical Report on drug shortages
Parenteral Drug Assn. expects to publish report on the prevention and management of drug shortages by early 2015.
September 10, 2014
Parenteral Drug Assn. expects to publish report on the prevention and management of drug shortages by early 2015.
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