Joanne Hawana on Food and Drug Administration (FDA)

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

Update on FDA’s Comprehensive Regenerative Medicine Framework: Looming November 2020 Deadline Preceded by a Flurry of Letters from...

As we discussed in our last update on the Food and Drug Administration’s Comprehensive Regenerative Medicine Policy Framework back in December 2019 (during the much simpler, pre-COVID-19 world), this coming November will...more

6/24/2020 / Adverse Events , Biologics , Center for Biologics Evaluation and Research (CBER) , Clinical Trials , Coronavirus/COVID-19 , FDA Warning Letters , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Investigational New Drug Application (IND) , JAMA

OTC Monograph Reform: Key Takeaways and What Industry Can Expect

On March 27, 2020, the President signed into law the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which in part describes reforms to modernize the regulatory framework for over-the-counter (OTC) monograph...more

6/10/2020 / Abbreviated New Drug Application (ANDA) , Administrative Orders , CARES Act , Food and Drug Administration (FDA) , Generic Drugs , Healthcare Reform , Over The Counter Drugs (OTC) , Pharmaceutical Industry , Prescription Drugs , Public Health , Rulemaking Process

FDA and FTC Continue to Trace and Fight Fraud Related to COVID-19

We have been blogging about the various actions that numerous government agencies were taking to combat COVID-19 fraud. These agencies and their respective law enforcement efforts have yet to slow down and appear to have...more

6/2/2020 / Cannabidiol (CBD) oil , Department of Justice (DOJ) , Domain Name Registration , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Marijuana , Public Health , Regulatory Oversight , Telemarketing , Warning Letters

Rough Seas for COVID-19 Serology Tests Lead to Course Correction by FDA

Responding to increased public and congressional criticism of its arguably too-flexible approach to regulatory oversight of serological tests used to detect COVID-19 antibodies, on May 4, 2020, the Food and Drug...more

5/7/2020 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Laboratories , Life Sciences , Pharmaceutical Industry , Virus Testing

COVID-19 and Lab Testing: What’s the Story Behind the Story?

Recently, newspapers and television news programs have been full of stories about laboratory testing and the important role it will play in containing the spread of COVID-19 and reopening U.S. economic activity. But these...more

5/5/2020 / CLIA , Clinical Laboratory Testing , Coronavirus/COVID-19 , Federal Food Drug and Cosmetic Act (FFDCA) , Food and Drug Administration (FDA) , Infectious Diseases , Public Health , Virus Testing

FDA Continues Its Diverse Agency Actions in Response to COVID-19 Pandemic

Since our last roundup-style blog post on the response of the Food and Drug Administration (FDA) to the COVID-19 public health emergency, the agency has taken a wide variety of additional actions with the goal of getting...more

4/22/2020 / Coronavirus/COVID-19 , Drug Approvals , Food and Drug Administration (FDA) , Health Care Providers , Medical Research , Medical Supplies

And Now For Something Completely Different: FDA Actions to Alleviate Regulatory Burdens For Product Sponsors During the COVID-19...

We’ve been blogging periodically on the various actions taken and enforcement policies being developed by the Food and Drug Administration (FDA) to support and expand the national response to the declared COVID-19 public...more

4/10/2020 / Adverse Events , Coronavirus/COVID-19 , Deregulation , Dietary Supplements , Food and Drug Administration (FDA) , Medical Devices , Regulatory Burden

Coronavirus Relief Bill Includes Surprise Addition: OTC Monograph Reform Bill Becomes Law

As a follow up to our recent blog post, FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round, President Trump signed the bipartisan over-the-counter (OTC) monograph reform bill into law on March 27, 2020....more

3/30/2020 / CARES Act , Coronavirus/COVID-19 , FDARA , Food and Drug Administration (FDA) , Generic Drugs , Legislative Riders , Over The Counter Drugs (OTC) , Over-the-Counter Sales , User Fees

Tackling False Claims Being Made for COVID-19 Treatments and Products

Two weeks ago, on March 9, the Federal Trade Commission (FTC) and the Food and Drug Administration (FDA) sent warning letters to seven companies that allegedly made false or deceptive claims about their products’ ability to...more

3/26/2020 / Coronavirus/COVID-19 , Deceptively Misdescriptive , Enforcement Actions , False Advertising , FDA Warning Letters , Federal Trade Commission (FTC) , Food and Drug Administration (FDA) , Fraud , Unfair or Deceptive Trade Practices , Warning Letters

1/27/2020 / Anti-Kickback Statute , Biologics , Drug Pricing , Food and Drug Administration (FDA) , Fraud and Abuse , Health Care Providers , Health Insurance Portability and Accountability Act (HIPAA) , Healthcare Fraud , Healthcare Reform , OCR , Pharmaceutical Industry , Stark Law

Joanne Hawana

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