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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 17

Quality Metrics Redux: Taking Advantage of FDA’s Renewed Focus

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

Editor's Picks

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FDA Warns Becton Dickinson for Potentially Contaminated Water, Environmental Conditions

The company promised to discontinue use of tap water.
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FDA Releases 25 Product-Specific Guidances for Generics

“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” said FDA Commissioner Scott Gottlieb.

FDA APPROVES ORCHID CHEMICALS' CEPHALEXIN

KEYWORDS Drug Pipeline Alert
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Orchid Chemicals and Pharmaceutical received approval from the FDA for its abbreviated new drug application (ANDA) of Cephalexin oral suspension. This is an off-patent molecule that forms part of Orchid's distribution alliance with U.S. generic pharma company, Par Pharmaceuticals.

The company believes that given the complexity of the formulation, it would have a good positioning in the generics market. Its Cephalexin capsules are already marketed in the U.S. in distribution partnership with Par. With the latest ANDA approval, the number of dosage forms, oral solids and injections distributed by Orchid in the U.S. stands at 12.