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Sponsors thinking of incorporating real-world evidence (RWE) into their submissions should consider RWE as just another form of clinical evidence, according to a recent presentation from a US Food and Drug Administration (FDA) official at the Orange County Regulatory Affairs Discussion Group annual conference.

The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review of medicines approved by two or more reference regulatory agencies.

In the last Regulatory IQ article, we talked about average review times for 510(k)s submitted in different months of the year. This prompts the question: What other factors contribute to review time variability?

The Indian government is preventing applicants who submit misleading, fake, or fabricated documents from filing further requests with regulatory authorities.

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, FDA published several guidance documents relating to drug-drug interaction studies, nonclinical evaluation of immunotoxicity, interstitial cystitis and its Q-submission program, and the agency announced it will allow another type of in-person, face-to-face meeting with drugmakers.

AMSTERDAM – European regulators will not prevent approval of a drug if the device part of the combination product is delayed in getting certification from a notified body, an European Medicines Agency (EMA) official assured delegates at RAPS Euro Convergence.

The Trump Administration's return-to-office mandate for federal employees, which also limits the hiring of remote workers, will restrict the US Food and Drug Administration's (FDA) talent pool and weaken the agency, according to Wilson Bryan, who served as the director of FDA's Office of Tissues and Advanced Therapies from 2016 until his retirement from the agency in 2023.

South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown.