Blog, page 4
Notes from our consultants on regulatory, clinical, quality, validation, IT and staffing topics.
DHS proposes H-1B modernisation rule
The October 2023 proposed rule set out beneficiary-centric selection, clarified specialty occupation criteria and addressed third-party placements.
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Vakula Connect, Q3 2023: Annex 1 takes effect; quality and sterile manufacturing in focus
Our Q3 2023 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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EU GMP Annex 1 applies from 25 August 2023
The revised Annex 1 on sterile manufacturing introduced contamination control strategy as a formal requirement.
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Vakula Connect, Q2 2023: E6(R3) draft, DCT guidance and the monitoring skills gap
Our Q2 2023 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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May 2023: ICH E6(R3) draft and FDA decentralised trial guidance arrive together
Two documents in one month set the direction for how trials will be run and monitored for the rest of the decade.
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FDA’s PREPP initiative: the five priority efforts
FDA’s Pandemic Recovery and Preparedness Plan set out where the agency would focus first. A summary of the initial efforts.
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FY2024 H-1B registration: a record year, and what it means for consultants
USCIS received well over 700,000 registrations for the FY2024 cap season. Selection odds fell sharply and the system came under review.
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Vakula Connect, Q1 2023: Record H-1B registrations and a cautious biotech market
Our Q1 2023 update for consultants and clients: market signals, the roles in demand, and what was new at Vakula Technologies Inc.
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FDORA 2022: diversity action plans and clinical trial modernisation
The Food and Drug Omnibus Reform Act, signed 29 December 2022, added statutory diversity action plan requirements and other trial provisions.
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