FDA Drug Topics: Frequently Asked Questions about Labeling for Prescription Medicines

FDA Drug Topics
FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians.
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Spotlight

OTHER ON-DEMAND WEBINARS

APPLYING LOW FREQUENCY RAMAN TO QBD IN PHARMACEUTICAL DEVELOPMENT

biopharma-asia

Low frequency Raman spectroscopy has been used to study various polymorphs and can be applied to the design of crystallization control strategy. Extending the low frequency spectral region to include the fingerprint region provides access to collective vibrations of molecules in the amorphous and crystalline states and yields valuable insight when differentiation of various forms is quintessential.
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How to Leverage Clinical IRT to Improve Clinical Trial Efficiency

Sharp Clinical Services

In this live webinar, our featured speaker will focus on the many attributes that must be considered to improve your clinical trial efficiency and experience. Participants will learn how to use the information you have from the protocol and clinical trial knowledge, along with clinical IRT expertise to ensure that the simple or complex randomization scheme is properly designed and set up to ensure flawless execution. As clinical trial success rests on delivering the right clinical treatment at the right place at the right time, the speaker will also illustrate supply chain optimization techniques which can be used as variables within clinical IRT to ensure this basic requirement is met.
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Developing Better Quality Controls in Advanced Therapy Medicinal Product (ATMP)

Advanced therapy medicinal products (ATMPs) comprise a category of innovative and complex biological products and hold one of the keys to personalised treatment. It holds promises as treatments for untreatable and high burden diseases.
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Studies of Mosquito Immunology and Plasmodium Virulence Using Imaging Flow Cytometry

Millipore Sigma

The classification of mosquito blood cells is controversial, complicated by the small size and number of cells one can obtain per mosquito, by the autofluorescent debris found in hemolymph, and the tendency of phagocytes to take up this autofluorescent debris. Much of the classification has been performed morphologically on cytospins of isolated cells. Imaging flow cytometry yields simultaneously acquired bright field, scatter, and fluorescent images of cells in suspension, enabling better resolution of rare cells from debris.
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