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GMP Inspection Preparation Checklist: A Tool for Internal Auditing

This management report includes more than 650 items organized in three sections covering all aspects of quality manufacturing.
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Biological Risk Evaluation and Management for Medical Devices

Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

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Oct 18

Retooling Risk-Based Quality Management Approaches in the Era of ICH E6(R2)

Oct 18

The CDER Reorganization: What It Means for Drugmakers

Oct 23

13th Annual FDA Inspections Summit

Oct 30

FDA Data Integrity: For Device and Pharma Firms, and Their Suppliers

Oct 30

Understanding ISO 19011:2018: The Path to Better Medical Device System Audits

Nov 1

SOPs and Policies for the 21st Century: Why Less is More

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MHRA Recalls Digital Pregnancy Tests

The recall affected one lot involving 58,000 tests distributed in the UK. 
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Miami Pharmacy Owner Admits to Submitting Over $8 Million in Fraudulent Medicare Claims

The plea followed an investigation by the Justice Department’s Medicare Fraud Strike Force.

SCHERING-PLOUGH TO EXPAND OPERATIONS IN BRAZIL

KEYWORDS Daily International Pharma Alert
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New Jersey-based Schering-Plough will establish Schering-Plough Produtos Farmaceuticos Limitada, a wholly-owned operation based in Sao Paulo, Brazil, to market its core products, and will restructure its agreement with Brazilian drugmaker Mantefarma, the company announced.

Schering-Plough entered into an agreement in 1991 with Mantefarma to market and distribute several products through Industria Quimica e Farmaceutica Schering-Plough, S.A. Under a new agreement, Mantefarma, which will now be known as Mantecorp, will continue to manufacture a number of Schering-Plough primary care products.

Schering-Plough Produtos Farmaceuticos Limitada will assume commercial responsibility for several specialty care products, including Peg-Intron (peginterferon alfa-2b), Temodal (temozolomide) and Caelyx (pegylated liposomal doxorubicin HCl). The company also will market the primary care products Zetia (ezetimibe), Zetsim (ezetimibe/simvastatin), Claritin (loratadine) and Clarinex.