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1,251 Results
Type: News
Section: Industry News > Regulatory
Materials
Helping consumers identify counterfeit products
United Nations report provides visual guide to educate consumers and protect brands.
May 2, 2013
Adherence/Delivery
Report says 40% of parents give young kids cough/cold medicine that they shouldn’t
Many parents disregard label warnings. …Meanwhile, FDA’s BeSafeRx provides interactive map tool to protect against fake pharmaceuticals.
April 24, 2013
Pharmaceuticals
Purdue Pharma receives FDA approval for OxyContin label language
New language describes abuse-deterrence studies conducted with reformulated tablets. Agency will not approve generics to original OxyContin.
April 23, 2013
Materials
Now introducing: Interphex 2013
Starring: 650+ suppliers, 1,000+ product lines, 52 conference sessions, special events and industry networking.
April 22, 2013
Materials
LIVE FROM PDA 2013: No cure for counterfeiting?
The tragic bombings in Boston grabbed headlines during the 2013 Parenteral Drug Assn.’s annual meeting in Orlando April 15-17, yet a presentation on biopharmaceutical counterfeiting was plenty frightening on a different level.
April 17, 2013
Materials
LIVE FROM PDA 2013: Pfizer examines managing the risks of outsourcing
Project management coordination is essential in moving a product through clinical and commercial development, especially on a global scale. Here’s how Pfizer made it work well.
April 16, 2013
Packaging/Filling
Vetter’s new commercial filling line validated and ready for cGMP filling
For prefilled syringes, line offers track-and-trace capability; first customer project underway.
April 8, 2013
Pharmaceuticals
ISPE releases new guidance on booklet labels
Organization says it’s the industry’s first-ever guidance to help companies conducting clinical trials globally standardize their use of booklet labels.
April 4, 2013
Pharmaceuticals
GS1 Healthcare US publishes new serialization guideline
Implementation of standards enables U.S. pharmaceutical companies to increase security, visibility, and control in the supply chain; guideline supports pending state drug pedigree requirements for implementation by 2015.
March 12, 2013
Adherence/Delivery
Reckitt Benckiser Pharmaceuticals Inc. receives FDA response to citizen's petition
FDA concludes that safety data presented by Reckitt Benckiser Pharmaceuticals did not warrant additional measures and that existing labeling/safety programs were sufficient.
February 27, 2013
Materials
Determining the future of EU medical device regulations
Device makers, lawmakers convene at Feb. 26 European Parliament committee meeting.
February 25, 2013
Pharmaceuticals
Serialization and track and trace
Pharmapack workshop on serialization reinforces challenges, draws some distinctions between Europe and the U.S.
February 15, 2013
Medical Device/Packaging
FDA’s Crowley addresses Unique Device Identification
The clock is ticking for medical device manufacturers to comply with deadlines.
February 13, 2013
Materials
Nanotechnology: Observing the regulatory frontier
Nanotechnology, combination products, and regulatory strategies frame the future in medical compliance issues, as noted in Feb. 12 MD&M West conference track.
February 12, 2013
Materials
Almac launches U.S. commercial packaging operations
Successful FDA inspection and new client partnership highlight $10 million-plus facility’s opening.
February 8, 2013
Nutraceuticals/Dietary
Novartis Consumer Health issues voluntary recall
Child-resistant feature of the bottle cap of certain lots of Triaminic Syrups and Theraflu Warming Relief Syrups may not function properly.
February 3, 2013
Materials
Combination products ruling in Federal Register
FDA issues rule on current Good Manufacturing Practice requirements applicable to combination products.
January 22, 2013
Pharmaceuticals
Readers’ picks: Top 12 Healthcare Packaging articles of 2012
Whether you embrace RFID or not, the topic itself registered as the most popular with Healthcare Packaging online readers in 2012.
January 4, 2013
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