FDA

2019 trends in regulatory approvals of new medicines

A study by the Centre for Innovation in Regulatory Science (CIRS) has identified trends in approvals of New Active Substances (NASs) by six major regulatory authorities1 , focusing on 2019 as well as the period from 2010 to 2019. In addition to tracking the number of approvals and the time to approval, the study also […]

Do EMA and FDA review outcomes for new active substances (NASs) align?

In order to better assure the safety and efficacy of pharmaceutical products, the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have taken steps to align their activities and goals. The Centre for Innovation in Regulatory Science (CIRS) and Sanofi partner on a study to evaluate their progress to date.   The common […]

COVID-19 testing: FDA guidance update

As SARS-CoV2 continues to spread, resulting in Coronavirus Disease 2019 (COVID-19) in patients, we examine FDA guidance on in vitro diagnostic testing and respirator use in healthcare settings, and highlight current trials for treatment and vaccines. The novel coronavirus, first detected in Wuhan City, Hubei Province, China, has now been detected in 50 locations worldwide, […]

Drug development challenge: Managing CMC submissions

In the era of Breakthrough Therapy and Fast Track drug designations, chemistry, manufacturing and controls (CMC) submissions can cause delays to bring a drug to market, said Drew Barlow, vice president, regulatory affairs at Syner-G Pharma Consulting.  Companies need to provide enough information to satisfy the regulatory requirements while recognizing that providing too much information early will […]

U.S. enhances malaria-fighting toolkit

In an unusual action, the U.S. Food and Drug Administration (FDA) asked an advisory committee to meet twice in two weeks this past summer to discuss nearly identical products with similar indications from two different pharmaceutical companies. During their vote, committee members noted the global need for additional agents for the prevention of malaria.   […]

FDA actions to improve prescription drug labeling for pregnancy

When healthcare providers look to prescribe a medication, ideally their decision is clear cut because ample clinical data exist in the relevant study populations. In reality, however, it is not uncommon that certain patient populations are not yet well captured, if at all, in prescription drug labeling. This is the case for pregnant women, who […]

FDA draft guidance addresses inclusion of adolescents in oncology trials

With an eye toward helping industry, investigators and institutional review boards (IRBs), the U.S. Food and Drug Administration (FDA) has unveiled draft guidance on the inclusion of adolescents—defined as those between the ages of 12 and 17—in adult oncology trials. Allowing adolescents in relevant trials would allow for earlier access to life-saving drugs in this […]

Regulatory considerations, strategy and best practices for choosing a quality CMO

Historically, the relationship between a sponsor and a CMO has been mostly transactional – one side manages items like regulatory filings and the other simply manufactures a specific product for a fee.  Today, however, said Bryan Coleman of the EAS Consulting Group, the market and regulatory environment require a much higher degree of collaboration and […]

FDA focuses on drug supply chain security

During the last year, the FDA has held a number of public meetings to focus on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA). The DSCSA outlines critical steps to build an electronic, interoperable system by November 2023, to identify and trace certain prescription […]