News & Insights Search

This is what six regulatory affairs professionals learned from their experience at the RAPS Kellogg Executive Development Program.

The US Food and Drug Administration (FDA) has warned several online retailers, including Walmart and Amazon, for selling unapproved chemical peel skin products. The agency noted that many of the products contain corrosive chemicals in high concentrations that are unsafe for use at home without medical supervision.

The US Food and Drug Administration (FDA) is asking for a nearly 5% increase in its budget for FY 2025, in part to provide its staff with pay increases to offset recent inflation.

The US Food and Drug Administration (FDA) wants sponsors and clinical trial researchers to present information to trial participants or their representatives early and concisely, making it easier to understand why they should or should not participate, according to a new draft guidance. The guidance also proposes communication strategies that can be used to ensure the information is more accessible.

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, Congress narrowly averted a government shutdown and FDA published an update to its recognized conformity standards for medical devices.

June Raine is set to step down from her position as chief executive of the UK Medicines and Healthcare products Regulatory Agency (MHRA) after serving in the role for five years and leading the agency through Brexit and the COVID-19 pandemic.

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 eyes are back on Congress as government shutdown deadlines approach, FDA created a digital health advisory committee, and published several guidances.

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's Peter Marks testified about vaccine safety on the Hill, the agency announced several notable drug approvals, and the agency extended an invitation to drugmakers to participate in its Site Tours Program.

Robert Califf, commissioner of the US Food and Drug Administration (FDA), said treatments for rare diseases and devices used to monitor people at home require new systems and regulatory pathways because the current ones are not suited for the job. He also said he's optimistic the agency will be able to implement its proposed Human Foods Program and Office of Regulatory Affairs (ORA) reorganization as planned and that he wishes Congress had passed diagnostics reform legislation.

Xavier Becerra, secretary of the Department of Health and Human Services (HHS), warned that if the US Food and Drug Administration (FDA) loses the upcoming Supreme Court case involving the abortion drug mifepristone, it could jeopardize the regulatory approval process and lead to lawsuits challenging the approval of other products by the agency.

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 the chair of the powerful House Energy and Commerce (E&C) committee announced she will not seek re-election, FDA announced several upcoming meetings, and two studies critical of the abortion drug mifepristone have been retracted by the publisher.

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 released a much-anticipated final rule reforming its quality system (QS) regulation and issued several guidances. Plus, Democratic lawmakers came to defend the agency's approval authority in a case involving the abortion drug mifepristone.