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Search: Page 39

1,251 Results
Type: News
Section: Industry News > Regulatory
Nutraceuticals/Dietary
GlaxoSmithKline Consumer Healthcare announces the return of alli
Weight-loss product returns to retail markets in tamper-evident packaging.
February 25, 2015
Weight-loss product returns to retail markets in tamper-evident packaging.
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
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
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
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.
Materials
LIVE FROM PHARMAPACK: Global pharma community accepts GS1 standards for identifying and capturing serialized codes
Non-profit group now turns attention to standards for sharing the data.
February 12, 2015
Counterfeiting info graphic sourced from Pharmapack website.
Regulatory
Hamburg’s resignation draws media reaction
FDA commissioner to step down in March, with Ostroff to serve as acting commissioner while Califf is named Deputy Commissioner for Medical Products and Tobacco.
February 10, 2015
Pharmaceuticals
Pfizer to acquire Hospira
The transaction is subject to customary closing conditions, including regulatory approvals in several jurisdictions and approval of Hospira's shareholders, and is expected to close in the second half of 2015.
February 9, 2015
Medical Device/Packaging
FDA requests $4.9 billion budget for FY 2016
The 9% increase over the FY 2015 budget aims to implement the agency’s Food Safety Modernization Act and improve quality and safety of medical products.
February 2, 2015
The U.S. Food and Drug Administration is requesting a budget of $4.9 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2016 budget—a 9% increase over the enacted budget for FY 2015.
Regulatory
Large Ebola vaccine trial opens in Liberia
The study is designed to enroll approximately 27,000 healthy men and women aged 18 years and older.
February 2, 2015
Materials
Recipharm delivers serialization project in China
Contract development and manufacturing organization works with unnamed pharmaceutical company, resulting in 57 successful batches since Feb. 2014.
January 30, 2015
Recipharm, a contract development and manufacturing organization, announced its readiness for serialization.
Regulatory
First generic version of Nexium approved
Ivax Pharmaceuticals, Inc. has gained approval to market esomeprazole in 20 and 40 milligram capsules.
January 29, 2015
Regulatory
Report looks at timeliness of FDA approvals
Although FDA drug and device approval time is improving, consistency needs to be key.
January 29, 2015
Materials
Unveiling Healthcare Packaging’s Top 10 from 2014
Website visitors seek insights on market trends and forecasts, serialization, unique device identification, and the benefits of effective package design.
January 20, 2015
Unveiling Healthcare Packaging’s Top 10 online articles from 2014.
Materials
Adherence packaging battles HIV/AIDS in Africa, India
Designed to help prevent the spread of HIV/AIDS in sub-Saharan Africa and India, MEMSCap smart electronic medication packaging system tracks each time the medication bottle is opened.
January 16, 2015
MEMSCap smart electronic medication packaging system tracks each time the medication bottle is opened.
Medical Device/Packaging
Alere recalls INRatio and INRatio2 PT/INR Monitor System
The firm received 18,924 reports of incidents, including 14 serious injuries.
January 9, 2015
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