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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. It’s been a busy week for the agency as Xavier Becerra, secretary of the Department of Health and Human Services, defended his department’s proposed FY2024 budget in the Senate, the agency released several guidances and reports, and announced upcoming meetings.
The US Food and Drug Administration (FDA) plans to hold at least one public meeting and release several guidances on digital health technologies (DHT) to be used in drug clinical trials by the end of the year. While it has issued guidances on digi...
One process that worked: For promising COVID treatments, EMA was able to provide enhanced presubmission dialogue with sponsors. EMA also was able to conduct “agile” assessments for promising treatments and ensure safety monitoring for these produc...
At the meeting, a panel of EMA officials, representatives of patient groups, and pharmaceutical industry representatives discussed some of the current challenges in conducting decentralized clinical trials in the EU, where differences among member...
The head of the US Department of Health and Human Services (HHS) is asking lawmakers for additional authorities to track product supply chains to avoid shortages and the need to give incentives to antimicrobial drug manufacturers to develop new pr...
India’s Central Drugs Standard Control Organization (CDSCO) implemented the New Drugs and Clinical Trials Rules in 2019 to expedite the drug development and approval processes. This article provides an overview of those processes; e...
“Many people initially who told us they were skeptical of its value understood that when you wanted to evaluate the safety or the effectiveness of the vaccine in everyday rollouts, it was RWE that was answering the critical questions. And all of ...
The UK will combine MHRA and ethics reviews and aim to complete assessments within 30 days of the validation of the application. Combining the reviews halved the review time, and reduced the time from application to first patient in, during a pilo...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
After the US Food and Drug Administration (FDA) solicited comments on an educational program for a new Empower Rare Disease Drug Developers (LEADER 3D) initiative in the Accelerating Rare disease Cures (ARC) program, nearly two dozen stakeholders ...
The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA) on finding the optimal dosage for cancer drugs could slow drug development. On the oth...
The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory submissions for investigational new drug applications (INDs), new drug applications (NDAs...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
The dispensing of lenalidomide Japan is covered by the RevMate control procedures because the drug molecule has a similar chemical structure to thalidomide and was shown to cause birth defects and abnormalities in animal studies.