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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.

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 leaders spelled out the case for an upcoming overhaul of the agency’s inspectional operations, the agency’s top biologics regulator proposed steps to make the US more attractive for early stage research, and the agency approved a controversial cancer drug after twice rejecting it.

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 announced a major reorganization intended to streamline operations, and the agency’s Cellular, Tissue, and Gene Therapies Advisory Committee (CTAGTAC) met this week to vote on whether to recommend therapies for Duchenne muscular dystrophy and melanoma.

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 acting FDA commissioner wrote an op-ed promoting the agency’s efforts to incentivize domestic drug manufacturing, FDA announced new grants for using digital health technologies (DHT) for drug development, and it approved an over-the-counter combination of two popular pain drugs.

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 staff raised concerns internally about conflicts of interest ahead of a panel on peptides next week, a top Democrat is seeking an investigation into the effects of the DOGE cuts on FDA, and the agency’s acting commissioner backtracked on some policies issued by his predecessor.

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, there were reports that the Trump Administration is reviewing candidates to head FDA, FDA was pressured to pause publishing complete response letters (CRL), and more.

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 named the seven companies that will participate in its PreCheck Pilot Program and opened its total product life cycle advisory program (TAP) pilot to products overseen by all of its Offices of Health Technologies (OHT).

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 HHS proposed several big measures to accelerate drug development, FDA warned about third-party testing facilities falsifying drug data, and the agency published several reports on the state of the drug industry and clinical trials.

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 announced new partnerships with two international regulators and reversed two notable decisions made under former top officials.

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. A key Senate committee will consider several important pieces of legislation that affect the healthcare products industry next week, FDA has approved a new sunscreen for the US market, and the agency published several guidances, including one on developing human genome editing products.