RAPS

FDA warns HIV test distributors, supplement firm, and OTC drugmaker

The US Food and Drug Administration (FDA) has cited several companies for marketing human immunodeficiency virus (HIV) serological diagnostic dried blood spot (DBS) card self-collection kits without a ...
RAPS

FDA finalizes guidance on considerations for evaluating drug’s benefits and risks

The US Food and Drug Administration (FDA) has finalized guidance that clarifies how the benefits and risks of a drug or biologic factored into the agency@s decisions on whether to approve a new drug ...
RAPS

FDA drafts guidance on cuffless blood pressure measuring devices

The US Food and Drug Administration@s (FDA) Center for Devices and Radiological Health (CDRH) has issued a draft guidance to assist manufacturers in submitting clinical performance testing to support ...
RAPS

2026 Combination Products in the EU

For the third consecutive year, DIA and RAPS are excited to jointly produce Combination Products in the EU on 27-28 January 2026 at the Radisson Collection Hotel, Grand Place Brussels. This ...
RAPS

CBER updates two guides for staff on reviewing INDs and handling clinical holds

The US Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) has updated two internal policy guides for its staff. The first guide outlines the procedures for ...
RAPS

Asia-Pacific Roundup: New Zealand’s Medsafe seeks feedback on planned changes to abbreviated filings

The Medicines and Medical Devices Safety Authority (Medsafe) is holding a consultation on plans to extend the abbreviated procedure for new medicine applications and certain change notifications. @ ...
RAPS

Twin Cities Chapter In Person Event: Regulatory Speed Mentoring: Building Next Generation of Regulatory Leaders

Kick off the 2026 RAPS Twin Cities Chapter with an evening of learning, networking, and mentorship! The Speed Mentoring Event is designed to connect early-career regulatory professionals with ...
RAPS

The Essential List of Regulatory Authorities in Europe

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RAPS

7-year FDA review finds improved GCP compliance

A study of routine good clinical practice (GCP) inspections between 2017 and 2023 found a declining number of Form 483s flagging violations at clinical trial sites and a very low number requiring ...
RAPS

FDA finalizes guidance on microneedling devices

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RAPS

9 Free Tools Regulatory Professionals Can use to Monitor the Regulatory Landscape

Tweet Deck Once a premium tool, Twitter's purchase of Tweet Deck several years ago has opened it up to the masses, and with it a useful set of tools that should be of interest to anyone interested in ...
RAPS

FDA trims reserve testing quantity requirements

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