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FDA orders Sun to hire manufacturing consultant for troubled plant as export pause persists

Fierce Pharma

FDA orders Sun to hire manufacturing consultant for troubled plant as export pause persists fkansteiner Tue, 05/16/2023 - 09:33

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Complying With FDA Regulations For Medical Device Training

Infuse Medical

If so, it is important to understand the regulatory requirements of the FDA. Do you know the FDA is the Food and Drug Administration? It is essential to understand the FDA’s definition of a medical device. Let’s see FDA regulations for medical device training.

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As FDA inspections return, upholding compliance and maintaining GMP readiness is more crucial than ever

pharmaphorum

Now FDA on-site inspections have resumed, with regulatory authorities returning to physical sites. Throughout the pandemic, the lack of FDA inspections has created new challenges and heightened existing problems, largely due to delays in upgrading legacy facilities. Upgrading facilities. Ensuring GMP readiness.

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Medical Devices Are Evolving Toward Specialized Solutions

MedCity News

In February of 2019, Johnson & Johnson acquired Auris Health and its FDA-cleared Monarch platform for $5.75 Later in 2019, Germany-based Siemens Healthineers announced its acquisition of Corindus and its FDA-cleared CorPath GRX System, a robotics platform specifically for percutaneous coronary interventions.

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Leap Consulting launches practice to assist labs with FDA’s LDT ruling

Pharmaceutical Technology

Leap Consulting Group has launched a practice aimed at guiding Clinical Laboratory Improvement Amendments-certified labs (CLIA) in adhering to the US Food and Drug Administration’s (FDA) Final Rule over the classification of laboratory-developed tests (LDTs).

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FDA approves first Stelara biosimilar, Wezlana

European Pharmaceutical Review

The US Food and Drug Administration ( FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level, without consulting the prescriber.

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FDA Enforcement Discretion: A Strategic Path to Market for Digital Health and Digital Therapeutics Companies

Nixon Gwilt Law

The FDA regulates all medical devices, including SaMD and DTx, but recognizes that not all pose the same level of risk to patients. For low-risk software devices, the FDA may exercise enforcement discretion, choosing not to enforce certain regulatory requirements. Which SaMD Device Functions May Qualify for Enforcement Discretion?