Tag archives: FDA

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

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

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

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

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

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”

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

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

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

FDA releases new guidance on off-label promotion

Last week, the U.S. Food and Drug Administration (“FDA”) released two guidance documents that relate to sharing of certain information about drugs and medical devices, including economic information about unapproved products and unapproved uses, as well as information not included in a product’s FDA-approved labeling. These guidance documents are part of broader blueprint published by … Continue reading

FDA releases 2017 enforcement statistics and recall draft guidance

On January 17, 2018, the U.S. Food and Drug Administration (“FDA”) released its 2017 enforcement statistics. Overall, the statistics showed that there were no food importation debarment enforcement actions in the past year. Notably, there were 15,318 warning letters issued, 9,199 products recalled, and 2,945 recall events. There were 12 injunctions, 5 drug product debarments, … Continue reading

FDA relaxes FSMA enforcement

On January 5, 2018, the U.S. Food and Drug Administration (“FDA”) released guidance entitled Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry. The guidance states that FDA will exercise enforcement discretion for certain parts of the Food Safety Modernization … Continue reading

FDA commissioner discusses key policy goals for 2018

On December 14, 2017, the Commissioner of the U.S. Food and Drug Administration (“FDA”), Dr. Scott Gottlieb, posted Looking ahead: Some of FDA’s major policy goals for 2018 on FDA’s blog, FDA Voice, and discussed FDA’s policy agenda published on the Unified Agenda of Federal Regulatory and Deregulatory Actions (“Unified Agenda”), which provides the public … Continue reading

FDA commissioner discusses upcoming guidance to modernize its framework for medical device review

On December 11, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, posted Advancing Policies to Promote Safe, Effective MedTech Innovation on FDA’s blog, FDA Voice and discussed FDA’s plans to modernize its policy framework for the review of new medical devices. These changes will require FDA to make the review process more … Continue reading

OIG rescinds advisory opinion to charity

For the first time, the OIG has rescinded an advisory opinion issued to a charity. According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 –  was revoked because the charity “failed to comply with certain factual certifications” about independence from donors, potentially steering Medicare beneficiaries toward certain prescription drugs. … Continue reading

FDA embraces medical innovation in 2017

On November 16, 2017, the US Food & Drug Administration (“FDA”) unveiled a comprehensive policy framework – a suite of four guidance documents – to oversee regenerative medicine products. Regenerative medicine is the science of restoring structure and function to damaged or diseased cells, tissues, or organs. The two final guidance documents outline when cell … Continue reading

FDA commissioner looks to curb tactics that restrict drug competition

On November 8, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke as a keynote speaker at the Federal Trade Commission (“FTC”) workshop, Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics (“Workshop”) and called to “end the shenanigans” that can delay or restrict generic drug competition. Gottlieb discussed his … Continue reading

FDA releases new guidances on increasing generic drug competition

The United States Food and Drug Administration (“FDA”) released four new draft guidances on October 2, 2017 that aim to reduce the barriers for certain generic drugs to enter the market and ultimately, reduce drug prices.  Reducing drug prices was a stated objective of President Trump during his campaign and has also been a topic … Continue reading

U.S. Senate Republican leadership decides against full Senate vote on Graham-Cassidy ACA repeal and replace legislation; HHS Secretary Tom Price resigns under pressure from the White House

On Tuesday, September 26, Senate Republican leadership decided not to hold a full Senate vote on the Graham-Cassidy Affordable Care Act (ACA) repeal and replace legislation. The previous day, Monday, September 25, the Senate Finance Committee held a hearing on the Graham-Cassidy bill. Following the hearing, Senator Susan Collins (R-ME) announced her opposition to the … Continue reading

FDA extends compliance date for Nutrition Facts Label rule

On June 13, 2017, the US Food and Drug Administration (“FDA”) announced that it was extending the compliance date for the Nutrition Facts Label rule. The FDA will provide the final details regarding the extension of the compliance date through a Federal Register Notice that it will publish at a later date. The FDA released … Continue reading

FDA / EMA parallel scientific advice principles published

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products. The PSA program provides scientific advice and protocol assistance in parallel to sponsors. “Sponsor” refers to: in the US, the sponsor of an Investigational … Continue reading

FDA and NIH finalize clinical trial protocol template

On May 2, 2017, the U.S. Food and Drug Administration (“FDA”) and The National Institutes of Health (“NIH”), through the NIH-FDA Joint Leadership Council, released the final version of a clinical trial protocol template in an effort to assist investigators conducting clinical trials and to create cost and time efficiencies in the medical product development … Continue reading

FDA announces plans to create a centralized digital health unit

The U.S. Food and Drug Administration (“FDA”) has announced plans to create a centralized digital health unit within the Center for Devices and Radiological Health (“CDRH”), further supporting CDRH’s 2016-2017 vision to establish a more robust national evaluation system for medical devices.  FDA will form the new digital health unit within CDRH’s Office of the … Continue reading
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