Joanne Hawana on Food and Drug Administration (FDA)

FDA Announces Review of Opioid Prescribing Regulations and Framework for Preventing Overdose-Related Deaths

The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing...more

9/8/2022 / DEA , Food and Drug Administration (FDA) , Opioid , Over The Counter Drugs (OTC) , Substance Abuse , Warning Labels

Recent FDA Warning Letter to Amazon.com Suggests the Agency Is Getting Tired of the Whack-a-Mole Game

Receiving a warning letter from the U.S. Food and Drug Administration (FDA) means that the agency has identified what it calls “violations of regulatory significance” and that you (as the recipient) need to take corrective...more

8/23/2022 / Amazon , Enforcement , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA)

Will a Nonprescription Birth Control Pill Be FDA’s First Approval under its Long-Awaited “ANCU” Proposed Rule?

Unintended downstream consequences are likely to abound in the wake of the June 24, 2022 Dobbs decision that overruled Roe v. Wade, as Mintz attorneys have addressed in other contexts here and here Those looking ahead have...more

7/21/2022 / Birth Control , Dobbs v. Jackson Women’s Health Organization , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GAO , Health Care Providers , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Roe v Wade , SCOTUS

Summer 2022 Is Here – Do You Know How the FDA User Fee Legislation Is Going?

Anyone who has spent any time around health care policymaking circles in Washington, D.C. has heard about the intense five-year cycle Congress goes through in order to reauthorize the biggest user fee programs at the Food and...more

6/2/2022 / BsUFA , Coronavirus/COVID-19 , Diversity , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , GDUFA , Medical Devices , PDUFA , Prescription Drugs , User Fees

FDA Expresses Displeasure with Consumer Products Containing Trendy Cannabis Ingredient Delta-8 THC

On May 4, 2022, the U.S. Food and Drug Administration (FDA) for the first time issued warning letters related to products containing delta-8 tetrahydrocannabinol (delta-8 THC). FDA has previously sent warning letters to...more

5/13/2022 / Advertising , Cannabidiol (CBD) oil , Consumer Product Companies , Controlled Substances Act , Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Marijuana

Co-Owner of Clinical Trial Company Pleads Guilty to Obstruction of Justice in Connection with Falsification of Clinical Trial Data

On January 12, 2022, the co-owner of a clinical research site in Miami, Florida pleaded guilty to one count of obstruction of justice after she knowingly lied to a United States Food and Drug Administration (FDA) investigator...more

1/18/2022 / Clinical Trials , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Guilty Pleas , Obstruction of Justice

Snapshot of Another Much-Too-Busy Year for FDA Before 2022 Really Gets Started

It is, somewhat amazingly, the beginning of January again. During this time of year we typically publish a series of blog posts that recap the most interesting Food and Drug Administration (FDA) activities over the prior 12...more

1/6/2022 / 21st Century Cures Act , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Fraud , Prescription Drugs , Vaccinations , Virus Testing , Warning Letters

The End Is (Somewhat) Nigh: FDA Begins Rolling Back Enforcement Policies Implemented in Response to the COVID-19 Pandemic

Over the course of 2020, the Food and Drug Administration (FDA) released numerous guidance documents covering diverse areas and aimed at increasing the availability of various medical products to prevent, treat, and diagnose...more

11/17/2021 / CDRH , Center for Drug Evaluation and Research (CDER) , Coronavirus/COVID-19 , Emergency Management Plans , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Goods or Services , Healthcare , Infectious Diseases , Medical Devices , Public Health Emergency , Relief Measures , Retail Market , Temporary Regulations

FDA Begins Modernizing its Resources and Implementing Over-The-Counter Monograph User Fee Requirements

By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill, which was included as...more

10/15/2021 / CARES Act , Code of Federal Regulations (CFR) , Food and Drug Administration (FDA) , Over The Counter Drugs (OTC)

FDA and FTC Coordination Appears to Be Escalating

Agencies of the federal government with a consumer protection mission have always tended to work closely together and to share information, but the COVID-19 pandemic has made those cooperative efforts even more visible to the...more

9/15/2021 / Consumer Protection Laws , Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Public Health Emergency

Biden Administration’s Drug Pricing Plan Calls for Bold Action by Congress

It’s finally here – the Drug Pricing Plan that President Biden ordered the Department of Health and Human Services (HHS) to produce by the end of August (the “Plan”) was released publicly by the Administration on September 9,...more

9/13/2021 / Biden Administration , Biosimilars Action Plan (BAP) , BPCIA , Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Drug Pricing , Executive Orders , Food and Drug Administration (FDA) , Medicaid Drug Rebate Program , Medicare Part B , Medicare Part D , MedPAC , Pharmaceutical Industry , Prescription Drugs

Ushering in a New Era: FDA Approves First Interchangeable Biosimilar

Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. biosimilar marketplace? Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee...more

8/5/2021 / Biosimilars , Biosimilars Action Plan (BAP) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Pharmaceutical Industry

Bipartisan VALID Act Re-Introduced in Congress: Is Diagnostics Reform on the Horizon?

In our most recent year-end blog post on devices and diagnostic products at the Food and Drug Administration (FDA), we summarized the tumultuous events of 2020 with respect to laboratory developed tests (LDTs) and clinical...more

7/13/2021 / Biden Administration , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Health Care Providers , Laboratory Developed Tests , Life Sciences

FDA’s Unapproved Drugs Initiative Revived, with Gusto!

Although we’ve now entered June of 2021 and President Biden has yet to nominate someone to serve as the Commissioner of Food and Drugs, current Acting Commissioner Janet Woodcock and her Senate-confirmed boss, Department of...more

6/8/2021 / Department of Health and Human Services (HHS) , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Pharmaceutical Industry , Prescription Drugs

FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results

The Food and Drug Administration (FDA) and the National Institutes of Health (NIH) have the authority to regulate clinical trial reporting requirements. Despite this authority, FDA and NIH have scantly enforced this area...more

5/6/2021 / Clinical Trials , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , National Institute of Health (NIH) , Noncompliance , Pharmaceutical Industry , Reporting Requirements

FDA Releases Ambitious Action Plan for Further Reducing Children’s Exposure to Toxic Elements from Foods

The U.S. Food and Drug Administration (FDA), industry, policymakers, and consumers share a common goal of ensuring that the foods and beverages Americans eat and drink are safe, and the law has long prohibited the...more

4/29/2021 / Baby Products , Children's Products , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply , OMB , Toxic Chemicals

FDA’s Biologics Inspections in the (Negative) Limelight: Will Congress or Executive Leadership Take Action?

In an unexpected twist to a troubling situation that began over two years ago, U.S. Special Counsel Henry Kerner penned a letter to President Biden on March 31, 2021 questioning the Food and Drug Administration’s (FDA’s)...more

4/9/2021 / Biden Administration , Biologics , Compliance , Food and Drug Administration (FDA) , Inspections , Manufacturers , Manufacturing Facilities , User Fees , Vaccinations , Whistleblowers

Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems

Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several...more

1/29/2021 / Biden Administration , CARES Act , Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Generic Drugs , Health Care Providers , Orange Book , PDUFA , Pharmaceutical Industry , Public Health Service Act , Regulatory Agenda

FDA in 2020: What a Year! (Part 3 of 3)

In addition to the incredible work of agency scientists and reviewers to get the first COVID-19 vaccines authorized for emergency use in December (as we covered in Part 2 of our year-end post), the Food and Drug...more

12/28/2020 / Biologics , Center for Biologics Evaluation and Research (CBER) , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Enforcement Actions , FDA Warning Letters , Food and Drug Administration (FDA) , Infectious Diseases , Over The Counter Drugs (OTC) , Prescription Drugs , Vaccinations

FDA in 2020: What a Year! (Part 2 of 3)

Following up on our colleagues’ post earlier this month covering the Food and Drug Administration’s 2020 device law and policy activities, this post will explore prescription drug and biologic law and policy developments over...more

12/22/2020 / Biologics , CDRH , Coronavirus/COVID-19 , Criminal Investigations , Department of Justice (DOJ) , Emergency Use Authorization (EUA) , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry

An Update on FDA’s Contribution to COVID-19 Diagnostic Testing

Back in the early days of the COVID-19 pandemic, we published a post outlining the different kinds of diagnostic tests that were being marketed and the different roles of the two main federal regulators that oversee the...more

11/6/2020 / Centers for Medicare & Medicaid Services (CMS) , CLIA , Clinical Laboratory Testing , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Diagnostic Tests , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Health Care Providers , Laboratory Developed Tests , Life Sciences , Over The Counter Drugs (OTC) , Virus Testing

FDA’s Prescription Drug Advertising Enforcers Issue COVID-19-Related Warning Letter

The U.S. Food and Drug Administration (FDA) recently announced what appears to be the first public warning made by the agency to a company promoting an approved prescription drug product for the unapproved use of treating...more

10/7/2020 / Coronavirus/COVID-19 , FDA Warning Letters , Federal Food Drug and Cosmetic Act (FFDCA) , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Health Care Providers , Intended Use , OPDP , Pharmaceutical Industry , Prescription Drugs , Proposed Rules

Final Canadian Drug Importation Rule and HHS Certification Issued Under Section 804 of the Food, Drug and Cosmetic Act

As previously covered on this blog, in mid-2019 the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) jointly published the Safe Importation Action Plan, which outlined the Trump...more

9/28/2020 / Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Federal Food Drug and Cosmetic Act (FFDCA) , Final Rules , Food and Drug Administration (FDA) , Imports , Infectious Diseases , Medical Supplies , New Regulations , Pharmaceutical Industry , Prescription Drugs , Secretary of HHS , Supply Chain

With Release of New Guidance, FDA Signals It’s Serious About Enforcing Clinical Trial Data Requirements

Clinical trial sponsors and principal investigators can consider themselves on notice that the Food & Drug Administration (FDA) is poised to ramp up enforcement activity relating to responsible parties’ obligations regarding...more

8/21/2020 / CDRH , Center for Biologics Evaluation and Research (CBER) , Center for Drug Evaluation and Research (CDER) , Clinical Trials , Final Rules , Food and Drug Administration (FDA) , Food and Drug Administration Amendments Act (FDAAA) , National Institute of Health (NIH) , New Guidance , Pharmaceutical Industry

Further Update on FDA’s Comprehensive Regenerative Medicine Framework: November 2020 Deadline Extended by Six Months

About a month ago, I predicted on this blog that Food and Drug Administration’s November 2020 enforcement discretion deadline announced as part of its Comprehensive Regenerative Medicine Policy Framework would most likely not...more

7/22/2020 / Center for Biologics Evaluation and Research (CBER) , Deadlines , FDA Warning Letters , Food and Drug Administration (FDA) , Health Care Providers , Regenerative Medicine , Time Extensions

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