The US Food and Drug Administration’s (FDA’s) Peter Marks, MD, directs the agency’s Center for Biologics Evaluation and Research (CBER). In a wide-ranging 6 November discussion with the president and chief executive officer of the Friends of Cancer Research, Jeff Allen, PhD, Marks spoke to tempering public expectation, sustaining CBER staff despite a crushing workload during the coronavirus pandemic, and the possibility of more changes in 2021.   Under a new adminis...

With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.   In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine d...

The European Medicines Agency (EMA) has begun a rolling review of the COVID-19 vaccine being developed by AstraZeneca and the University of Oxford. This is the agency’s first review of a vaccine against SARS-CoV-2, the virus that causes COVID-19.   EMA’s human medicines committee (CHMP) has begun with an evaluation of non-clinical data, announced EMA on 1 October. The rolling review is meant to hasten the time to a decision on the safety and effectiveness of a therap...

Seven former commissioners of the US Food and Drug Administration (FDA) came together to call out the Trump administration for undercutting FDA’s credibility as the agency prepares to evaluate clinical trial data for vaccines against SARS-CoV-2, the virus causing the novel coronavirus pandemic.   Their comments, made in an opinion column published 29 September in The Washington Post , were welcomed by the FDA’s current vaccines chief, Peter Marks , MD, PhD, directo...

Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine .   Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposi...

For the first time, the US Food and Drug Administration (FDA) on Friday listed medical devices in shortage or that have been discontinued during the coronavirus disease (COVID-19) public health emergency using a new authority under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   The CARES Act amended the Federal Food, Drug, and Cosmetic Act by adding Section 506J, which requires manufacturers of certain devices to notify the agency of manufa...

At an event marking the launch of Moderna’s Phase 3 clinical trial for its mRNA coronavirus vaccine in Miami on Monday, US Food and Drug Administration (FDA) Commissioner Stephen Hahn repeated assurances that his agency would not cut corners in approving a COVID-19 vaccine.   Pfizer also announced on Monday that it would begin a Phase 2/3 study of its COVID-19 vaccine developed in partnership with BioNTech. Both companies say they plan to enroll 30,000 participan...

Key Democratic members in the US House of Representatives have called on Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.   In a letter dated 18 June, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairma...

With the closure of a medical device sterilization facility in Illinois, the US Food and Drug Administration (FDA) warned of device shortages, and last Friday announced a type of a tracheostomy tube manufactured by Smiths Medical is the first to be in shortage. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement : “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization chal...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Singapore’s HSA Apologizes After Vendor Stores Data in Vulnerable Repository   Singapore’s Health Sciences Authority (HSA) has apologized to blood donors after a vendor stored their information in a vulnerable database. HSA learned the database lacked adequate safeguards from a cybersecurity expert and does not think other unauthorized people accessed the information...

A lot of ink has been spilled on the controversial random suffixes that the US Food and Drug Administration (FDA) is now tagging on the end of the nonproprietary names of biologics and biosimilars. Back in January 2017, FDA finalized a guidance document spelling out how this four-letter, FDA-designated meaningless suffix would be attached at the end of biologics’ and biosimilars’ nonproprietary names. Later in 2017 and 2018, companies began to realize FDA was only u...

How a generic drug is priced may be the difference between whether it experiences a shortage or not, a new study published in Value in Health found. The study of commonly used outpatient generic drugs from 2008 to 2014 found that the prevalence of shortages decreased from a peak in 2011-2012 to less than 4% of the overall sample by the end of 2014. Generic drug prices “were strongly predictive of drug shortages,” the researchers found. But competition and market si...