Articles by Amy Ritter - Pharmaceutical Technology

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Articles by Amy Ritter

First Seasonal Influenza Vaccine Produced in Cell Culture Approved in US

Nov 26, 2012

Novartis announced that it has received FDA approval for a seasonal influenza vaccine produced in cell culture, the first seasonal vaccine produced by this method to be approved in the US.

FDA Adopts Final Version of Q11 Guidance

Nov 20, 2012

FDA announced the availability of the guidance “Q11 Development and Manufacture of Drug Substances†in the Nov. 20, 2011 edition of the Federal Register.

Legislators Request Info on Link Between Drug Shortages and Increased Reliance on Compounding

Nov 19, 2012

House Democrats have requested the Government Accountability Office (GAO) to conduct an inquiry into factors leading to an increased reliance on compounded products.

Raid Captures 82 Million Doses of Counterfeit Drugs in Africa

Nov 12, 2012

An operation spanning 16 African countries and conducted by the World Customs Organization (WCO) in partnership with the Institute of Research against Counterfeit Medicines (IRACM) led to the seizure of more than 82 million doses of counterfeit medicines.

Boehringer Ingelheim Settles False Claims Act Allegations for $95 Million

Nov 5, 2012

Boehringer Ingelheim has agreed to pay $95 million to settle allegations that it improperly promoted four of its drugs.

Watson Receives Clearance for Actavis Acquisition

Oct 22, 2012

Watson Pharmaceuticals has received clearance from the Federal Trade Commission for its acquisition of generic drug manufacturer, Actavis.

Novasep to Build the World's Largest Chromatography Plant

Oct 15, 2012

Novasep announced that it will be investing EUR 30 million ($39 million) to build what will be the world's largest chromatography plant for the production of large volumes of commercial APIs.

FDA Investigates Compounded Medication Tied to Meningitis Outbreak

Oct 8, 2012

FDA announced that it is working closely with the Centers for Disease Control (CDC) to identify the source of an outbreak of meningitis among patients who had received an epidural steroid injection.

Technical Forum: Disposable Chromatography

PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems.
Oct 2, 2012

PharmTech spoke with industry experts about the challenges of implementing disposable chromatography systems.

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