Blog

Sciformix is committed to sharing ideas and insights with the life science industry and support the development and commercialization of safe and effective products. Our employees and partners share their knowledge and thought leadership.

What Does The First Biosimilar Approval By The USFDA Mean For The Pharmaceutical Labeling Industry?


Bindu Narang

The advent of generic products made a significant contribution to patients worldwide by providing access to affordable medicine. Biosimilars will deliver a similar promise. However, the regulatory challenges in the approval of biosimilars are very different and more complex because unlike generics,...

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Dr. Suhasini Sharma

Pregnancy Exposure Registries & The New FDA Pregnancy & Lactation Labeling Rule (PLLR)


Dr. Suhasini Sharma

[This post discusses the importance/benefits of pregnancy registries; and the new labeling rule – PLLR – proposed by the FDA/EMA for pharmaceutical and biological products used by Pregnant and Lactating women.] Women of childbearing potential form a sizable proportion of the population...

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Dr. Chitra Lele, Chief Scientific Officer, Sciformix

Pharmacovigilance Outsourcing: The Need for Parity Between Local Presence and Offshore Capabilities in a Global Delivery Model


Dr. Chitra Lele Ph.D.

[This post analyzes considerations and requirements of a global delivery model for pharmacovigilance.] The drug safety landscape continues to evolve with the dynamic pharmaceutical marketplace. Increased regulatory requirements, importance of emerging markets, global partnerships across multiple stakeholders and shifting mix of small...

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