Regulation and Compliance - BioPharm International


Regulation and Compliance

FDA Seeks More Timely Drug Information Electronically

March 1, 2010

The new Sentinel system aims to expand access to data on medical product safety and patient effects.

Biotech Manufacturing Under Scrutiny

February 1, 2010

Trouble at Genzyme and with flu vaccine production illustrates the challenges in producing safe and potent biologics.

Quality by Design and Compliance Readiness

January 1, 2010

How will implementing Quality by Design strategies affect your compliance status?

Issues and Opportunities Challenge Biotech Manufacturers

January 1, 2010

Demand for new vaccines and therapies in 2010 will be offset by concerns about drug prices and product safety.

The Promise and Perils of Vaccines

December 1, 2009

Vaccine research and development is surging, but continues to face manufacturing and regulatory challenges.

QbD and GMPs: How the Convergence of Science and Compliance Will Change the Way We Work

November 1, 2009

The focus on the design space will lead to a new workspace, and will affect staff in the development, manufacturing, and quality functions.

Safety First in Biotech Development

November 1, 2009

Heightened attention to product safety issues is slowing the approval process for new therapies.

FDA Leaders Stress Science and Compliance

October 1, 2009

Stiffer enforcement of quality standards aims to restore public confidence in agency actions.

Biopharmaceutical Manufacturers Seize Opportunities in the Global Health Arena

September 1, 2009

The FDA is encouraging manufacturers to invest in research and development for new vaccines and therapeutics to combat third-world diseases.



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