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ProPharma’s team of dedicated experts is at the forefront of both existing and emerging industry trends. ProPharma’s team inspires tomorrow by leveraging rich data insights across our service lines and functional areas to develop innovative solutions that answer the most complex needs of both existing and prospective clients.

Agency Alerts General Regulatory

October 29, 2015

FDA Guidance: Nonclinical Safety Evaluation of Reformulated Drug Products & Products Intended for Administration by an Alternate Route

Published on October 27, 2015, the guidance document outlines a number of recommendations for the nonclinical evaluation of previously approved drug substances when a new formulation or a new route...

Agency Alerts General Regulatory

October 12, 2015

FDA Insider Shares Thoughts on Priority Review Vouchers

FDA’s priority review voucher program allows drug makers to receive expedited review of drug products intended to treat rare or neglected diseases (more details in our blog post here). The program...

Agency Alerts General Regulatory

October 5, 2015

Sandoz vs. Amgen, Round Two

Sandoz, the generic pharmaceuticals division of Novartis, is the global leader in biosimilar products. On March 6, 2015, FDA approved Zarxio, a biosimilar version of Amgen’s Neupogen (filgrastim)...

Agency Alerts General Regulatory

September 15, 2015

FDA Reviews First NDA for “Digital” Medicine Product

FDA has accepted for review the first NDA for a “digital” medicine product. The product, which is produced by Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health, is the first-ever medication...

General Regulatory Drug Approval

April 9, 2015

Will There Ever Be An FDA-Approved Generic Insulin?

On February 25, 2015, FDA approved Toujeo, a once-daily, long-acting recombinant insulin. A year earlier an inhaled formulation of insulin, Afrezza, was approved. These recent additions to the...

General Regulatory Drug Approval

April 22, 2014

FDA Thinking on Biosimilar Immunogenicity Issues - A Case Study Based on the Enoxaparin ANDA Approval

Following extensive marketing of Lovenox® (enoxaparin sodium), a low-molecular weight heparin, a number of biosimilar versions of enoxaparin and one ANDA-approved formulation (enoxaparin sodium,...

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Inspiring the Future of Drug Development

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