FDA Law Blog: Biosimilars

AUGUST 18, 2024

By Véronique Li, Senior Medical Device Regulation Expert & Jeffrey N. Gibbs — In 1997, Congress wisely amended the Federal Food, Drug, and Cosmetic Act (FDCA) by adding Section 513(f)(2) to establish the De Novo process. The De Novo process provides a regulatory pathway to classify novel devices for which general controls alone or general and special controls provide reasonable assurance of safety and effectiveness for the intended use.

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Drugs.com

AUGUST 18, 2024

SUNDAY, Aug. 18, 2024 -- As kids head back to school this fall, there is probably one item many parents haven't thought to put on the to-do list: dental checkups.But they should make sure their children's teeth are in good shape, said Dr. Natasha.

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ProRelix Research

AUGUST 18, 2024

Although time, speed, and operational constraints have long plagued the progress of clinical trials, another factor that remains important and has been gaining prime importance as the centre of clinical […] The post Putting Patients First: The Shift Towards Patient-Centric Clinical Trials appeared first on ProRelix Research.

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Perficient: Drug Development

AUGUST 18, 2024

What Is a Salesforce Approval Process An approval process in Salesforce is a set of steps that automate how records are approved in your organization. It specifies the actions to take when records are submitted for approval, who must approve them, and what happens after approval or rejection. This process ensures that important business decisions and changes to records are reviewed and authorized by the right people consistently and efficiently.

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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

Clinical Trials

Drug Patent Watch

AUGUST 18, 2024

Dabigatran etexilate mesylate is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Apotex, Hetero Labs Ltd Iii, and Boehringer Ingelheim and, and is included in five NDAs.

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Chemical Biology and Drug Design

AUGUST 18, 2024

The present work systematically gives a comprehensive review in current developments of benzimidazole–oxadiazole hybrid compounds in the whole range of medicinal chemistry and the perspectives that they hold for future research. ABSTRACT To increase the success rate of drug discovery, one practical strategy is to begin molecular hybridisation. The presence of two or more pharmacophores in a single unit leads to a pharmacological potency greater than the sum of each individual moiety's potency.

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Pharmacokinetics Drugs Research 100

Drug Patent Watch

AUGUST 18, 2024

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Spain.

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