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Following the trend of other regulators, the European Medicines Agency (EMA) is taking steps to reduce the need for animal testing. The agency has issued a draft qualification opinion for a new approach methodology (NAM) using virtual control groups (VCG) in dose range finding studies that reduce the need for concurrent control groups that use animals.

The US Food and Drug Administration (FDA) has finalized guidance on incorporating patient preference information (PPI) for assessing the benefit-risk profile of certain medical devices throughout the total product life cycle.

The European Medicines Agency (EMA) has released a concept paper proposing a future reflection paper on the development of non-clinical proof-of-concept (POC) studies to support novel oncology treatments for the pediatric population.

The US Food and Drug Administration (FDA) has updated its guidance to cut regulatory burdens on biosimilar manufacturers by reducing the need for conducting pharmacokinetic (PK) studies. The agency said that sponsors may meet their regulatory requirements by submitting analytical data rather than PK studies.

In a new draft guidance, the US Food and Drug Administration (FDA) has provided details on the clinical investigation requirements that sponsors of new drugs must meet to obtain three years of marketing exclusivity for their products.

Senators and expert witnesses voiced concerns about the US Food and Drug Administration's (FDA) oversight of rare disease therapies during a hearing of the Senate Special Committee on Aging on Thursday. These concerns included claims of inconsistent review processes, the agency's failure to apply regulatory flexibility, and the issuance of nearly two dozen complete response letters (CRLs) for rare disease treatments since the start of 2025.

The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has published a new guidance agenda that outlines the guidance it plans to release this year, including both new and revised guidance documents. This latest agenda features several additions to the agency's list.

The US Food and Drug Administration (FDA) issued warning letters to a medical device manufacturer and a homeopathic drug manufacturer for failing to meet current good manufacturing practices (CGMP) requirements. The agency also cited another device maker for marketing products without authorization and failing to comply with clinical trial requirements.

The top lawmaker on the Senate Health, Education, Labor, and Pensions (HELP) Committee published a report this week on reforming the US Food and Drug Administration (FDA). The report argues the changes would cut red tape, make the US more attractive to clinical research, and accelerate the approval of medical products.

The US Food and Drug Administration (FDA) will, by default, require only one clinical trial to demonstrate that a product meets its regulatory requirements for safety and efficacy in most cases, according to two top officials. Former top FDA officials who spoke to Focus raised concerns about how the policy was developed and announced.

The US Food and Drug Administration (FDA) has issued warning letters to a contract drug maker for failing to meet current good manufacturing practices (CGMP) and a clinical investigator for failing to ensure site staff complied with the clinical investigation plan.

Pharmaceutical companies and EU industry groups pushed back against the expectation for sponsors to justify their choice to use adaptive clinical trial designs in the International Council on Harmonisation's E20 guidance on adaptive clinical trials in comments submitted to the European Medicines Agency (EMA).

The European Medicines Agency (EMA) has announced that its pilot program for the stepwise pediatric investigation plan (sPIP) has successfully supported timely pediatric development while maintaining scientific rigor. This program will be incorporated into the existing pediatric regulatory landscape.

US Food and Drug Administration (FDA) Commissioner Marty Makary said he wants to see the same sense of urgency given to Operation Warp Speed applied to the agency's Commissioner's National Priority Voucher (CNPV) program.

BRUSSELS – European Commission officials say they have proposed legislative changes to the European Parliament that they hope will ease regulatory requirements for sponsors of combined studies based on ongoing pilot projects.

The European Medicines Agency (EMA) has published a revised guideline on the development of drugs aimed at treating peripheral arterial occlusive disease (PAOD) in the lower extremities. It will take effect on 30 June 2026.

The US Food and Drug Administration (FDA) issued a draft guidance on Friday to assist sponsors in using Bayesian methods to support the safety and effectiveness of new drugs in clinical trials. These methods utilize information from previous studies to accelerate the drug development process.

The US Food and Drug Administration (FDA) has reissued guidance aimed to enhance the enrollment and retention of females in clinical trials and non-interventional studies, removing references to gender, diversity, and intersex traits that were included in an earlier version released during the Biden administration.