Regulatory Policy & Regulations Articles - BioPharm International

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Regulatory Policy & Regulations Articles

FDA Panel Unanimously Backs Secukinumab for the Treatment of Psoriasis

October 22, 2014

An advisory committee recommends use of the first psoriasis therapy targeting IL-17A.

FDA Works to Secure Drug Supply Chain

September 1, 2013

New FDA supply chain policies aim to strengthen inspection and oversight processes.

FDA Urges Greater Focus on Contractor Quality

July 1, 2013

Increased manufacturer outsourcing requires clear policies and written agreements with CMOs.

EU Battles Medicine Shortages

July 1, 2013

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

Should Regulation of Combination Products Become More Centralized in Europe?

May 1, 2013

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Regulatory Convergence Sought for Global Pharma Market

May 1, 2013

Manufacturers work with international authorities to harmonize drug registration and supply-chain oversight.

State of Quality and Compliance in the Biopharmaceutical Industry

April 1, 2013

Have FDA initiatives improved manufacturing quality?

Advancing QbD in the EU

April 1, 2013

EU authorities are stepping up their efforts to incorporate QbD principles.

Navigating Emerging Markets — Latin America

April 1, 2013

Latin America's diverse growing market seeks regulatory harmonization.

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