Blog, page 3
Notes from our consultants on regulatory, clinical, quality, validation, IT and staffing topics.
H-1B modernisation final rule published, effective January 2025
The final rule codified beneficiary-centric selection, clarified specialty occupation criteria and updated third-party placement rules.
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Vakula Connect, Q4 2024: H-1B final rule and a strong year-end for quality roles
Our Q4 2024 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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FDA finalises decentralised clinical trial guidance
The September 2024 final guidance confirms how sponsors and investigators should run trial activities away from traditional sites.
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Vakula Connect, Q3 2024: Decentralised trials finalised; hybrid studies become normal
Our Q3 2024 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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Vakula Connect, Q2 2024: The LDT rule and laboratory regulation
Our Q2 2024 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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FDA finalises the laboratory developed test rule
The May 2024 final rule phased out FDA’s enforcement discretion for LDTs over four years, bringing laboratory tests into device regulation.
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Vakula Connect, Q1 2024: QMSR final rule and the beneficiary-centric lottery
Our Q1 2024 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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FDA publishes the QMSR final rule: two years to align with ISO 13485
Published 2 February 2024 with an effective date of 2 February 2026, the rule incorporates ISO 13485:2016 into FDA device quality requirements.
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Vakula Connect, Q4 2023: H-1B modernisation proposed; planning for the QMSR
Our Q4 2023 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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