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HP&M Seeks Experienced Regulatory Expert

FDA Law Blog: Biosimilars

Specifically, manufacturing/testing procedures and compliance with cGMPs. Conducting internal investigations and audits of manufacturing facilities for compliance with 21 CFR 211/600. Preparing for and responding to government inspections and other compliance matters. Strong verbal and writing skills are required.

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FDA Releases Final Guidance on Use of Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

FDA Law Blog: Biosimilars

For these devices that do not have market authorization and are only used for remote data collection in a clinical investigation, if the sponsor conducts verification and validation activities consistent with the guidance to demonstrate the DHT is “fit-for-purpose,” FDA does not intend to assess sponsors’ compliance with design controls.

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HP&M Welcomes Senior FDA Official, Ana Loloei, to the Firm

FDA Law Blog: Biosimilars

Loloei tackled legal matters related to various aspects of the regulation of medical devices, in vitro diagnostics, and combination products including regulatory and compliance issues, dispute resolutions between the FDA and sponsors, and FDA enforcement actions. During her FDA tenure, Ms. Gibbs , HP&M Director.

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HP&M Files Comments Opposing FDA’s Proposed LDT Rule

FDA Law Blog: Biosimilars

The PRIA also omits entire other categories of costs, such compliance with 21 C.F.R. Part 11, the need to hire new laboratory personnel, and engage outside experts such as Contract Research Organizations, biostatisticians, lawyers, and software engineers.

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Amgen To Acquire Privately Held Teneobio For $900 Million In Cash With Future Contingent Milestone Payments

The Pharma Data

“Over the last five years, Teneobio developed leading-edge expertise in efficiently engineering differentiated multispecific and bispecific therapeutics for numerous indications with potentially better safety, efficacy and pharmacokinetic profiles than the first generation of T-cell engagers. chief executive officer of Teneobio.

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IQVIA vs Vial | Pros and Cons

Vial

Importantly, unlike IQVIA, Vial’s EDC is entirely developed by an internal software engineering team, reducing vendor dependencies. This approach replaces paper sources, supports productivity-enhancing workflows, and ensures compliance with relevant regulations.

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Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area.

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