Viewpoints
Viewpoint: GDUFA Off to Good Start, But Storm Clouds on the Horizon
By John DiLoreto, Executive Director of the Bulk Pharmaceuticals Task Force
GDUFA is off to a good start from a facility inspection perspective, but there are storm clouds on the horizon.
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Viewpoints
New Dynamics in Drug Pricing and Prescribing
What price can (or will) patients pay for the needed therapy? Changes in prescribing and regulatory practices worldwide continue to shape the financial outlook of biopharmaceutical companies.
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Outsourcing
Climate Change Drives New Opportunities in Outsourcing
By Jim Miller
Ongoing changes create new opportunities for CROs and CMOs.
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API Sourcing and Manufacturing
Deficiencies Discovered in API Inspections Suggest Strategies for Improvement
PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.
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Corporate Social Responsibility
BMS Grants Support Mental Health Needs of US Military Veterans
The Bristol-Myers Squibb Foundation is awarding 10 grants to fund programs for veterans and their families.
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Corporate Social Responsibility
Jimmy Carter and Pfizer Mark 15-Year Effort To Help End Blinding Trachoma
Former US President Jimmy Carter and Pfizer commemorate the 15th anniversary of the International Trachoma Initiative to end blinding trachoma by the year 2020.
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Corporate Social Responsibility
Janssen Announces Drug Donation Program for HIV Treatment-Experienced Children
Janssen's donation program will improve access to the company's approved HIV medicines for children and adolescents in sub-Saharan Africa.
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