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Understanding the Elements of a Typical IND-Enabling Package

The Premier Consulting Blog

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. Primary pharmacology examines the on-target effects on the drug such as receptor binding.

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Companies Shipping Chemicals: “Know the One You’re Dancing With”

FDA Law Blog: Biosimilars

Attorneys Office for the Western District of Texas announced that IMC Pro International Inc. DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 IMC Pro did not store or handle the packages nor maintain records about their contents. of 1-BOC-Piperidone and 138.66

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More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

FDA Law Blog: Biosimilars

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. By Sarah Wicks & Anne K. Walsh The recent and drastic Reduction In Force (RIF) at the U. However, not all information contained in FDA records is disclosable.

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Tutorial 4 – Microservices – Discovery Client, LoadBalancer Client and Feign Client.

Perficient: Drug Development

It uses LoadBalancerClient internally, which means it selects the target microservice instance from a list of service instances with a lower load factor. So, other instances of the target may sit idle. To solve these problems, use the “ LoadBalancerClient ” type client component.

Packaging 104
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Optimizely CMS – Custom form element with dependencies

Perficient: Drug Development

Optimizely CMS comes with a package called Episerver.Forms that enables you to incorporate easy to build forms within a CMS website. The internal forms js kicks in to do the actual show/hide of the element based on this cssClass. So what happens now?

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Data Cloud Workshop: From Readiness to Results

Perficient: Drug Development

Our Salesforce Data Cloud Workshop is a partial or full-day session designed to: Build education and internal alignment around Salesforce Data Cloud. Our Data Cloud Activation Packages can help you launch Salesforce Data Cloud in as little as two to 20 weeks. Clarify your current data ecosystem and future-state vision.

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From Bench to Bedside and Back Again: Strategies for effectively leveraging preclinical data to accelerate

Fierce BioTech

Is your organization harnessing the full potential of preclinical metadata for analyses, internal decision making, and to support R&D packages? Is your organization harnessing the full potential of preclinical metadata for analyses, internal decision making, and to support R&D packages? Download now.