As we enter the third year of the COVID-19 pandemic, consumers are increasingly turning to dietary supplements to help them manage the daily stress of this unprecedented time. However, as demand for dietary supplements associated with stress and anxiety-reduction has increased, so has regulatory scrutiny from the US Food and Drug Administration (FDA) and Federal Trade Commission (FTC). This article provides an overview of the FDA and FTC’s regulations and enforcement activ...

The COVID-19 pandemic caused one of the most prominent displays of supply chain disruption in the modern era. However, the US Food and Drug Administration (FDA) found ways to allow for regulatory flexibility by issuing guidance documents while still managing to protect consumers from adulterated and misbranded food.   Keywords – COVID-19 , FDA, food, guidance, pandemic, supply chain   Introduction The complexity of modern supply chains is never more eviden...

Heeding the advice of its expert advisory committee, the US Food and Drug Administration (FDA) on Thursday recommended the inclusion of an Omicron BA.4/5 spike protein component in modified COVID-19 vaccine boosters for the upcoming fall and winter seasons.   The recommendation follows a 19-2 vote in favor of adding an Omicron-specific component to future boosters by FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) earlier this week. (RELATED:...

A panel of experts recommended the inclusion of an Omicron component in future COVID-19 vaccine boosters in the United States. Public health officials suspect another surge in COVID-19 cases this fall and are considering boosters with an updated strain composition in hopes that vaccine targeting a more recent strain of the virus will be more effective.   FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on 28 June to discuss whether the a...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel to advise on whether — and how — Covid vaccines should be updated ( STAT ) ( NYTimes ) ( Endpoints ) ( Fierce ) Pfizer/BioNTech say Omicron-based COVID shots improve response vs that variant ( Reuters ) FDA places partial clinical hold on David Hung biotech after certain cancer patients experience eye inflammation ( Endpoints ) Astellas’ gene therapy...

On Wednesday, the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of amending FDA’s emergency use authorization (EUA) for Moderna’s two-dose vaccine to include children 6 months through 5 years of age. The committee voted separately in favor of recommending to amend Pfizer’s EUA for its vaccine and authorize use of a three-dose vaccine for children 6 months through 4 years of age.   In a 21-0 v...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Advisers Review Pfizer, Moderna Covid-19 Vaccines in Young Children ( WSJ ) ( STAT ) ( Reuters ) US pivots to ‘harm reduction’ after 107,000 overdose deaths last year ( FT ) Briefing docs for Acadia's Alzheimer's-related psychosis resubmission reveal an undecided FDA ( Endpoints ) Bristol Myers asks Supreme Court to revive $1.2 bln cancer-drug patent win (...

The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously to recommend Moderna’s COVID-19 vaccine as a two-dose series for emergency use authorization (EUA) in children 6 years and older.   The committee met on Tuesday to discuss Moderna’s COVID-19 vaccine EUA request to include children and adolescents 6 years through 17 years of age. Moderna sought an EUA for a two-dose primary series for adoles...

This article summarizes the requirements for transitioning medical devices, marketed with lowered standards for effectiveness under emergency use authorization (EUA) during the COVID-19 pandemic, after the EUA declaration expires. These policies may evolve as the US Food and Drug Administration (FDA) awaits declaration from the secretary of Health and Human Services (HHS) stating that the pandemic has ended. The author suggests this limited oversight of the manufacture of ...

The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021.   These are some of the areas highlighted in OCC’s latest annual report released 2 May, de...

The US Food and Drug Administration (FDA) on Tuesday signed off on a second round of COVID-19 vaccine booster shots for immunocompromised individuals and people 50 years of age and older.   The agency said the boosters can be administered four months after receiving the first booster dose of any authorized or approved COVID-19 vaccine in both populations.   The populations covered by the latest authorizations differ from those sought by the two vaccine makers. Pfiz...

Responding to two US Food and Drug Administration (FDA) draft guidances on transitioning products granted emergency use authorization (EUA) during the pandemic to regular marketing authorizations, key stakeholders raised concerns the agency isn’t providing enough time to collect the necessary data or make labeling changes after the current public health emergency (PHE) is over.   In December, FDA published two much-anticipated draft guidances titled, “ Transition Plan ...