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In the latest paper, Swissmedic and swissethics have added two new sections to the list of DCT elements, created three appendices, and made changes to the existing text. The two new sections cover trial oversight and responsibilities and organizational aspects for good clinical practice inspections.

HTAR states the JCA report 'should be factual and should not contain any value judgment.” Assessments of the certainty of study results must remain descriptive at the European level and avoid conclusions that may interfere with independent decision-making at the national level.

Industry groups, clinical researchers and patient advocates praised draft guidance from the US Food and Drug Administration (FDA) and the Office of Human Research Protections (OHRP) that makes recommendations on the key information that should be included in informed consent documents used in human subjects research.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

Industry and patient groups are asking the US Food and Drug Administration (FDA) to take a flexible approach when reviewing changes that come with switching third-party vendors that provide services for Risk Evaluation and Mitigation Strategies (REMS), also known as REMS administrators. The groups argue that a restrictive approach could limit patient access to life-saving drugs.

Two proposed regulations to limit the use of ethylene oxide (EtO) and the facilities that use the sterilizing agent could have a 'devastating” impact on the medtech industry and patient access to life-saving products, according to two industry groups.

The US Food and Drug Administration (FDA) is looking for up to nine drugmakers to join a pilot program intended to improve transparency for oncology drugs that rely on in vitro diagnostics to identify patients who may benefit from a particular treatment. Use of so-called companion diagnostics has increased with the proliferation of targeted therapies in recent years, especially in the oncology space.

In the US Food and Drug Administration (FDA) Accelerated Approval program, the tradeoff for early approval of medicines is that confirmatory evidence is required in the postmarket setting. In a special communication in JAMA Health Forum, health policy experts argue that FDA should put in place similar postmarket safeguards for any drug approval that has some uncertainty about clinical benefit.

The US Food and Drug Administration (FDA) has finalized guidance that lists non-clinical testing information the agency wants from sponsors of tissue containment systems used with gynecological and other types of laparoscopic power morcellators (LPMs). The guidance is meant to ensure containment systems are reasonably designed to catch cancerous tissue to prevent its spread.

The US Food and Drug Administration (FDA) has proposed new drug labeling requirements to make it easier for patients to understand their medication while improving prescription adherence. The agency also argues that the rule will save manufacturers and regulators both time and resources.

WASHINGTON – The US Food and Drug Administration (FDA) plans to reform its advisory committee system, and stakeholders should expect upcoming changes, FDA Commissioner Robert Califf said in a video presentation at the Food and Drug Law Institute (FDLI) Annual Conference.

Monovalent messenger ribonucleic acid (mRNA) COVID vaccines from Moderna and Pfizer/BioNTech are no longer authorized for use in the US, the US Food and Drug Administration announced 18 April. Instead, the emergency use authorizations (EUAs) for their bivalent vaccines have been amended so they can be updated more easily in the future.

The US Food and Drug Administration (FDA) chastised India-based Lupin in a recent untitled letter for a multitude of good manufacturing practice (GMP) violations, including lax investigations into equipment failures and poor complaint follow-up.

The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD) guidances meant to help sponsors collect and incorporate patient experience information that can factor into regulatory decision making. The latest guidance focuses on how clinical outcomes assessments (COA) can be used as endpoints to support a product.

The US Food and Drug Administration (FDA) last week issued draft guidance offering insights to sponsors and institutional review boards (IRBs) on the process for referring research involving children in cases where such research would not normally be approvable by an IRB. In such cases, an IRB may refer the study to FDA or the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP).

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.

More than 10% of drugs granted accelerated approval by the US Food and Drug Administration (FDA) have not complied with the agency's 2019 labeling guidance, according to a new study. The study authors wrote that the lack of labeling transparency can affect prescribing habits and call on FDA to ensure regulatory compliance through meetings with manufacturers, warning letters or by levying fines.

The head of the US Food and Drug Administration's (FDA) drug center said the agency has prioritized addressing the ongoing opioid pandemic over the past year to ensure drugs are used safely. In particular, the agency pointed to several initiatives such as going after online retailers selling illegal opioids and taking steps toward getting over-the-counter (OTC) naloxone to market.

The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year. It includes several rules that the Food and Drug Administration (FDA) will work on to address issues such as patient labeling, conduct of clinical trials and drug compounding.