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FDA sends warning letter to KVK-Tech manufacturing facility

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has sent a warning letter to KVK-Techs drug manufacturing facility following an inspection in April 2019. The document identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Whats next for KVK-Tech?

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Obesity Medication Use Remains Low Among Children | ADA 2025

Drug Topics

from 2017 to 2020. image credit: syahrir / stock.adobe.com While data shows that obesity has been on the rise among children in recent history, the overall complications spurred on by childhood obesity have been well documented. . Dispensing of glucagon-like peptide-1 receptor agonists to adolescents and young adults, 2020-2023.

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STAT+: Brain biopsies on ‘vulnerable’ patients at Mount Sinai set off alarm bells at FDA, documents show

STAT

In March 2020, as Bauman was preparing to undergo the surgery at a Mount Sinai medical facility in midtown Manhattan, he said he was invited to participate in a research study — one only open to patients already committed to undergo DBS at Mount Sinai. The review, which lists consultations with 16 different FDA officials, was scathing.

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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

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A Temporary Extension for the Rare Pediatric Disease Priority Review Voucher with a Longer-Term Extension in Sight?

The FDA Law Blog

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

On February 7, at a town hall organised to discuss clinical trial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases.

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FDA looks at pulling speedy approvals for three cancer drugs

pharmaphorum

FDA advisors will scrutinise three cancer immunotherapies granted conditional approvals at a three-day meeting this week, to see if they should stay on the market. . Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies.

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