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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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Jan 29

Developing Pharmaceutical Investigational Brochures & Annual Reports: Secrets to Practical Succes...

Jan 30

Regulating Software Used by Life Science Manufacturers: Is it a Medical Device or Not?

Feb 13

Building a World-Class Drug Supply Chain: Tips for Compliance and Digital Transformation

Feb 19

Medical Device Risk Management: Prepare for the Winds of Change

Mar 20

Medical Device Complaint Management: Escape the Labyrinth

Mar 26

Conducting Advanced Root Cause Analysis and CAPA Investigations

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Gramercy’s Nitinol Staple System Cleared by FDA

The device provides an array of sterile symmetric and asymmetric, barbed and smooth staples.
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Stakeholders Offer Feedback on New National Drug Code Format

Among other options, the agency proposed a new, expanded 12-digit format.

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.