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The highly-anticipated fifth edition is here! Get the must-have resource for achieving compliance with medical device regulations.
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Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.
A Dutch producer of active pharmaceutical ingredients (APIs) was put on notice to adopt more robust equipment cleaning practices and use better safeguards to prevent cross-contamination in a warning letter from the US Food and Drug Administration ...
Updated 01 July with new information on Paxlovid, Evusheld, molnupiravir, Regkirona and ivermectin.
Regulatory professionals need a new guide to medical device regulations. We just wrote one.
Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall and winte...
This article explores the role of a generalist and a specialist within the regulatory profession, as well as considerations in today's evolving regulatory landscape. To decide on the best path forward, it is important to understand ...
The US Food and Drug Administration (FDA) this week issued a sweeping draft guidance intended to help stakeholders incorporate patient experience data through the use of meaningful clinical outcome assessments (COAs).
Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration ...
MHRA proposed a slate of medtech reforms considering the Cumberlege Review and the opportunity presented by Brexit. The proposals were intended to improve patient safety, increase transparency, more closely align the UK with international practice...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
A global regulatory group is seeking industry participants for two pilot programs exploring a common regulatory framework for assessing manufacturing facilities in hybrid inspections and for reviewing postapproval changes.
Both industry and clinicians asked the US Food and Drug Administration (FDA) for clarification related to the evaluation of cellular starting materials in its draft guidance on chimeric antigen receptor (CAR) T cell product development.
The former top US Food and Drug Administration (FDA) cybersecurity expert says it’s only a matter of time before disaster strikes in the form of a medical device exploit that could harm patients. To get ahead of the problem, he said the agency nee...