thought leadership

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.

FDA North America

April 27, 2022

Drug Products, Including Biological Products, that Contain Nanomaterials

Guidance for Industry April 21, 2022 Nanotechnology can be used in a broad array of FDA-regulated products, such as human drug products, including those that are biological products.3 Nanotechnology...

ANDA FDA

April 27, 2022

Providing Submissions in Electronic Format — Postmarketing Safety Reports

GUIDANCE DOCUMENT April 2022 This guidance is one in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for...

FDA North America

April 26, 2022

Coronavirus (COVID-19) Update: FDA Approves First COVID-19 Treatment for Young Children

April 25, 2022 Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at...

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Inspiring the Future of Drug Development

We’ve developed a process that suits the today’s needs and a better experience for clients. Our industry is constantly changing. Let us help you accelerate your innovation.