Regulatory: Page 100

Regulatory
FDA warns against hidden drug in weight loss supplement
The agency found the product contained a controlled substance that was removed from the market in October 2010 for safety reasons.
March 2, 2015
Medical Device/Packaging
Planning for a new national medical device surveillance system
New report says regulators and experts have outlined a plan for medical devices, and the patients who use them.
March 2, 2015
Medical devices within an operating room.
Nutraceuticals/Dietary
GlaxoSmithKline Consumer Healthcare announces the return of alli
Weight-loss product returns to retail markets in tamper-evident packaging.
February 25, 2015
GlaxoSmithKline Consumer Healthcare announces the return of alli
Materials
Sanaria uses logistics partnership to support Malaria vaccines
Biotech firm works with Cryoport to develop a robust distribution and delivery systems network to help children in Africa most at risk of the disease.
February 24, 2015
Shown here is is a schematic of Cryoport's liquid nitrogen dry vapor shipper.
Regulatory
Sterility concerns prompt national injection recall
The recalled Atracurium Besylate Injection was manufactured by Emcure Pharmaceuticals Ltd. and distributed by Sagent Pharmaceuticals.
February 24, 2015
Materials
Sproxil Inc.: Product verification technology
With Mobile Product Authentication, smartphone users can verify products and avoid counterfeits.
February 20, 2015
Sproxil Inc.: Product verification technology
Regulatory
New draft documents related to compounding of human drugs issued by FDA
It includes information on drug repackaging, as well as mixing, diluting, and repackaging biological products.
February 19, 2015
Materials
West Pharmaceutical Services: Vial seals
Sterile, ready-to-use drug vial seals help pharmaceutical manufacturers ensure drug safety.
February 18, 2015
West Pharmaceutical Services: Vial seals
Pharmaceuticals
FDA issues guidance for repackaging
Repackaging of certain human drug products by pharmacies and outsourcing facilities contains nonbinding recommendations.
February 18, 2015
Pharmaceuticals
FDA issues new draft documents related to compounding of human drugs
Documents include draft guidances on outsourcing facility registration; outsourcing facility adverse event reporting; drug repackaging; mixing, diluting, and repackaging biological products; and a draft Memorandum of Understanding with the states.
February 13, 2015
FDA issues new draft documents related to compounding of human drugs
Materials
Serialization to meet Turkey’s requirements
A massive serialization project is completed in an impossibly tight timeframe by taking a modular approach across 24 packaging lines and by assembling a tight-knit team.
February 13, 2015
INBOUND CARTONS. As cartons visible in the lower right corner are conveyed into a case packer, a camera reads all 100 unique car
Materials
LIVE FROM PHARMAPACK: What will new European regulations for medical devices mean for the industry?
As a result of all the uncertainty, medical device manufacturers are left in a bit of a predicament.
February 12, 2015
Panelists talk during one of the panel educational sessions at Pharmapack Europe.
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