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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. This week, Senators grilled President Trump’s nominee to lead FDA during her confirmation hearing, and the agency published a rule to aimed at reducing animal testing.

CHARLOTTE, NC — Whether the US Food and Drug Administration (FDA) will accept clinical evidence from outside the United States (OUS) depends on if the investigations followed good clinical practice (CGP) regulations, but the data should also be applicable for regulatory purposes.

Heidi Overton, President Donald Trump’s nominee to lead the US Food and Drug Administration (FDA), faced questions from both sides of the political aisle about her views on hot-button issues facing the agency during a Senate confirmation hearing on Thursday.

Emer Cooke and other EMA leaders have weighed into the debate about whether sponsors should run one or two pivotal trials, arguing that the decision should be informed by the evidence needed to show a positive benefit-risk balance.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Audit-ready organizations don't wait for an audit to start checking whether their quality system works.

Pharmaceutical industry groups largely support the US Food and Drug Administration’s (FDA) proposed rule on distributed manufacturing but are seeking clarification on how the proposed model would function and specific changes they say would make it easier to implement distributed manufacturing models.

"Regulatory professionals are extremely knowledgeable," she says. "Sometimes that actually creates a communication problem."

CHARLOTTE, NC — While new approach methodologies (NAM) offer a path to reduced reliance on animal testing, experts say global regulators need to agree on their use to give sponsors predictability and regulatory assurance.

CHARLOTTE, NC — Officials from the US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency (MHRA), and other European regulators said that successful meetings with sponsor involved transparency, open collaboration, listening, early communication, and having sufficient data to answer questions.