Tag archives: FDA

COVID-19 Update: Vaccine No. 4 and the CDC’s Quarantine and Isolation Calculator

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on March 30, 2022 Posted in Coronavirus, General

Yesterday, March 29, 2022, the CDC launched a new calculator designed to help individuals exposed to COVID-19 discern how many days of quarantine and/or isolation are necessary. This tool was created in order to aid in the prevention of spreading the virus. Users are first prompted to select whether they have tested positive for COVID-19 … Continue reading

COVID-19 Update: New Variants and Vaccine Research

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on February 11, 2022 Posted in Coronavirus, General

During a recent Q&A, a representative with the World Health Organization warned that the Omicron variant is not the last of its kind. Dr. Maria Van Kerkhove explained that the next variant is likely to be more transmissible and could be more deadly than any of the previous variants. Although receiving the COVID-19 vaccine remains … Continue reading

COVID-19 Update: Panel of FDA Vaccine Advisers Vote in Favor of Vaccination for Children

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on October 26, 2021 Posted in Coronavirus, General

On Tuesday, October 26, 2021, the FDA’s Vaccines and Related Biological Products Advisory Committee members voted to approve vaccinations for children aged 5 through 11. Specifically, the panel addressed the following question: “Based on the totality of scientific evidence available, do the benefits of the Pfizer . . . Vaccine when administered as a 2-dose … Continue reading

COVID-19 update: Efficacy of mask use and vaccinations for children

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on October 7, 2021 Posted in Coronavirus

On October 1, 2021, the CDC issued its weekly “Morbidity and Mortality” report and noted according to a July 1 – September 4, 2021 study that “[s]chool mask requirements, in combination with other prevention strategies, including COVID-19 vaccination, are critical to reduce the spread of COVID-19 in schools.” The study analyzed “differences between county-level pediatric … Continue reading

COVID-19 update: Availability of the Pfizer vaccine

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on September 20, 2021 Posted in Coronavirus

On September 17, 2021, the US Food and Drug Administration’s (“FDA”) Vaccines and Related Biological Products Advisory Committee rejected Pfizer’s application for the booster shot of its COVID-19 vaccine for all individuals. The advisory committee was tasked with discussing Pfizer’s supplemental application for administration of this third dose for individuals aged 16 and older, and … Continue reading

CMS issues proposed rule repealing Medicare pending new “reasonable and necessary” definition and HHS issues proposed rule implementing provisions of the No Surprises Act

By Mark Faccenda (US), Thomas Dowdell (US) and Hayley Coley (US) on September 20, 2021 Posted in General, Regulatory

On Wednesday, September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule that would, among other things, repeal the pending new definition for items and services that are considered “reasonable and necessary” under Medicare Parts A and B scheduled to go into effect on December 15, 2021. Proposing to repeal … Continue reading

COVID-19 update: FDA warns against COVID-19 vaccine for children younger than twelve

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on September 13, 2021 Posted in Coronavirus

On September 10, 2021, the Acting Commissioner of Food and Drugs, Janet Woodcock, M.D., and Director of the Center for Biologics Evaluation and Research, Peter Marks, M.D., PhD., issued a statement on behalf of the FDA regarding the vaccination of children under the age of twelve. The FDA noted there are different issues that need … Continue reading

COVID-19 Update: Pfizer vaccine fully approved by FDA

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on August 23, 2021 Posted in Coronavirus, FDA & Food Safety

On August 23, 2021, the US Food and Drug Administration (“FDA”) granted full approval for the Pfizer-BioNTech COVID-19 (“Pfizer”) vaccine for individuals sixteen-years-old and older. This change shifts the vaccine from emergency-use only and is the first COVID-19 vaccine granted approval by the FDA in the United States. For individuals aged twelve through fifteen, the … Continue reading

COVID-19 Update: FDA announces availability of COVID-19 booster shot for immunocompromised

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Hannah Putnam (US) on August 13, 2021 Posted in Coronavirus

On August 12, 2021, the United States Food and Drug Administration (“FDA”) authorized a COVID-19 vaccine booster for immunocompromised individuals. Because booster vaccines were not previously authorized under the FDA’s emergency use authorization, the FDA’s announcement today was a necessary step to begin administering booster vaccines. This is the first time an additional dose of … Continue reading

COVID-19 Update: Pfizer-BioNTech Vaccine Approved for Teens

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on May 11, 2021 Posted in Coronavirus, General

On May 10, 2021 the U.S. Food and Drug Administration (“FDA”) announced that the Pfizer-BioNTech Emergency Use Authorization (“EUA”) would be expanded to include children ages 12-15. Previously, the vaccine had been approved for individuals 16 and older. The press release stated that between March 1, 2020 and April 30, 2021 there were approximately 1.5 … Continue reading

COVID-19 Update: First COVID-19 vaccine approved in UK

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on December 2, 2020 Posted in Coronavirus, FDA & Food Safety, International

On December 2, 2020 the United Kingdom’s Medicines and Healthcare Products Regulatory Authority (“MHRA”) announced approval of Pfizer and BioNTech’s coronavirus vaccine. According to a press release from the U.K. government: This was done using a regulatory process known as a ‘rolling review’. A ‘rolling review’ can be used to complete the assessment of a … Continue reading

COVID-19 Update: First EUA for COVID-19 Vaccine Filing Imminent; CDC Urges Americans Not to Travel for Thanksgiving

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on November 20, 2020 Posted in Coronavirus, FDA & Food Safety, General

On Friday November 20, Pfizer and BioNTech announced they would submit a request to the U.S. Food and Drug Administration (“FDA”) seeking Emergency Use Authorization for their vaccine candidate. Earlier this week, the companies announced that at the completion of their Phase 3 trial, the vaccine was 95 percent effective. In addition to the effectiveness, … Continue reading

COVID-19 Update: Progress toward a vaccine candidate

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on November 10, 2020 Posted in Coronavirus, FDA & Food Safety, General

On November 9, Pfizer and its German counterpart BioNTech announced initial clinical results found their coronavirus vaccine candidate to be more than 90 percent effective. Pfizer will wait to seek Emergency Use Authorization (“EUA”) from the US Food and Drug Administration (“FDA”) under Section 564 of the Food, Drug, and Cosmetic Act. Clinical study subjects must … Continue reading

COVID-19 Update: Biopharmaceutical Executives Release Joint Statement on Vaccine

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on September 9, 2020 Posted in Coronavirus, FDA & Food Safety, General

Chief executive officers of nine biopharmaceutical companies signed an unprecedented joint pledge, entitled BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE, acknowledging the U.S. Food and Drug Administration’s (“FDA”) role in the development of a COVID-19 vaccine, and pledging to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to … Continue reading

CMS Publishes Proposed Rule on Medicare Coverage for Innovative Technologies

By Thomas Dowdell (US), Mark Faccenda (US), Jeff Wurzburg (US) and Hayley Coley (US) on September 4, 2020 Posted in General, Regulatory

On September 1, 2020, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule that would establish a new Medicare coverage pathway, Medicare Coverage of Innovative Technology (“MCIT”), for medical devices that are designated by the Food and Drug Administration (“FDA”) as breakthrough devices. Under the proposed MCIT pathway, CMS would provide national … Continue reading

HHS Issues Proposed Rule on Good Guidance Practices

By Jeff Wurzburg (US), Thomas Dowdell (US) and Hayley Coley (US) on August 25, 2020 Posted in Coronavirus, General, Regulatory

On August 20, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a proposed rule that would impose requirements regarding the issuance and reliance on HHS guidance documents. This proposed rule results from the 2019 U.S. Supreme Court decision in Azar v. Allina Health Services (139 S. Ct. 1804). In this case the … Continue reading

COVID-19 Update: FDA Inspections Signal Resumption of Government Enforcement Efforts

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on July 14, 2020 Posted in Coronavirus, General, Regulatory

On July 10, 2020, the U.S. Food and Drug Administration (FDA) announced it would resume domestic on-site inspections beginning the week of July 20. Due to the COVID-19 pandemic, the FDA suspended inspections of facilities in March “to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.” To … Continue reading

COVID-19 Update: FDA revokes EUA for malaria drugs used as COVID-19 treatment

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on June 15, 2020 Posted in Coronavirus, FDA & Food Safety, General

On June 15, 2020, the U.S. Food and Drug Administration (FDA) revoked emergency use authorization (EUA) for chloroquine (CQ) and hydroxychloroquine (HCQ). The FDA found that the criteria for issuance of the EUA are no longer met and “in light of ongoing reports of serious cardiac adverse events and several newly reported cases of methemoglobinemia … Continue reading

COVID-19 Update: FEMA Issues Interim Final Rule Allocating Scarce or Threatened Materials

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on April 9, 2020 Posted in Coronavirus, General, Regulatory

On April 7, 2020, the Federal Emergency Management Administration (“FEMA”) released a final rule pursuant to the Defense Production Act (“DPA”) and Executive Orders issued by President Trump prohibiting the export of the scarce or threatened materials identified by President Trump on April 3, 2020. HL Pulse summary is available here. Specifically, the Executive Order … Continue reading

COVID-19 Update: HHS Letter Permits Hospital Sharing of Ventilators

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on March 31, 2020 Posted in Coronavirus, General, Regulatory

On March 30, 2020, a letter to hospitals from U.S. Surgeon General Jerome Adams and U.S. Department of Health and Human Services Assistant Secretary for Health Adm. Brett Giroir released Guidelines to Optimize the Use of Mechanical Ventilators permitting the use of a single mechanical ventilator for two patients. However, this “strategy should only be … Continue reading

COVID-19 Update: Coronavirus Designated a Pandemic by WHO

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on March 11, 2020 Posted in Coronavirus, General

On Wednesday the World Health Organization declared COVID-19 a pandemic. WHO Director-General Tedros Adhanom Ghebreyesus stated that “In the days and weeks ahead, we expect to see the number of cases, the number of deaths and the number of affected countries climb even higher.” In a hearing before the House Oversight and Reform Committee Dr. … Continue reading

FDA Final Rule Amends Definition of “Biological Product”

By Rachel Park (US), Jeff Wurzburg (US) and Mark Faccenda (US) on March 3, 2020 Posted in FDA & Food Safety, General

On February 20, 2020 the U.S. Food and Drug Administration (FDA) published a final rule, revising the regulatory definition of biological products to match the definition Congress agreed to in the Further Consolidated Appropriations Act, 2020. The changes reflect the FDA’s efforts to remove regulatory hurdles in order to create cheaper versions of biological products, … Continue reading

COVID-19 Update: US Expands Travel Restrictions After First Fatality

By Yvonne Puig (US), Daphne Andritsos Calderon (US) and Jeff Wurzburg (US) on March 2, 2020 Posted in Coronavirus, General

On Saturday, the State of Washington announced the first fatality in the United States arising from the coronavirus, with a second announced on Sunday. Washington Governor Jay Inslee has declared a state of emergency. As of Monday March 2, 2020, there were 89,197 total confirmed cases of COVID-19 worldwide and 3,048 resulting deaths. U.S. Secretary … Continue reading

FDA publishes new 510(K) guidance

By Yvonne Puig (US), Mark Faccenda (US) and Jeff Wurzburg (US) on January 24, 2019 Posted in FDA & Food Safety

On January 22, 2019, the FDA released nonbinding guidance expanding the Abbreviated 510(k) program used to show the safety and efficacy of medical devices. A new “safety and performance-based pathway” for certain, well understood device types, may be used by manufacturers to demonstrate substantial equivalency to devices already on the market. Under the 510(k) process, … Continue reading