Ferdous Al-Faruque

BALTIMORE – Risk management remains the top reason the US Food and Drug Administration (FDA) investigators cite medical device makers for failing to meet their quality management requirements, according to a top agency official. She emphasized that companies need to treat risk management as an ever-evolving responsibility.

BALTIMORE – Experts said who spoke at the RAPS Quality Conference on Wednesday said that a successful quality culture must come from the top and be continuously reevaluated. They added that employees need to feel empowered to ask questions and trust that their company is transparent with them.

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.

The US Food and Drug Administration (FDA) has published draft guidance for applicants for new drug applications (NDAs) and NDA holders on submitting patent information to their NDAs using Form FDA 3542a or Form FDA 3542. The guidance is intended to help applicants and holders submit patent information using the correct form to their NDA and aims to answer commonly asked questions.

The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to meet quality system and current good manufacturing practice (CGMP) requirements. The agency has also cited more than two dozen telehealth companies for marketing compounded glucagon-like peptide-1 (GLP-1) receptor agonist drugs without authorization.

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.

The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological product development, reflecting significant stakeholder feedback it has received since the original draft was proposed. Among the updates is a new section on evaluating drug effects across multiple diseases, conditions, or disease subtypes in basket trials.

The US Food and Drug Administration (FDA) has cited several online companies, including retail giant Amazon, for selling products that have not been evaluated for safety and efficacy by regulators. It also warned a two drugmakers for failing to meet its current good manufacturing practices (CGMP) requirements, including falsifying laboratory testing data.

Several industry groups and drugmakers have written to the US Food and Drug Administration (FDA) to ask the agency to harmonize its recent draft guidance on developing fermentation and semi-synthetic antibiotics with global regulators. They also said the guidance lacked significant detail and asked the agency to harmonize terminologies.

The US Food and Drug Administration (FDA) says two marketing videos submitted by Pinnacle Biologics make misleading statements about the company's cancer drug Photofrin (porfimer sodium), noting that the lack of details about the drug's full indication and limitations, especially insufficient statements about its risks, could mislead healthcare providers.