On 15 January 2025, the US Food and Drug Administration (FDA) announced that it will revoke the color additive authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingestible drugs. This ban...more
In this episode, Michael Hinckle and Rebecca Schaefer provide an overview of FDA’s recently issued draft guidance on decentralized clinical trials. They review the goals of the guidance to promote diversity in clinical...more
6/1/2023
/ Biologics ,
Clinical Trials ,
Comment Period ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Medical Centers ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Comment ,
Regulatory Requirements ,
Scientific Research
In this episode, Rebecca Schaefer and Michael Hinckle review some types of hospital and health system activities that could trigger FDA regulatory oversight. They discuss the FDA’s jurisdiction over IRB’s in medical device...more
The U.S. Food and Drug Administration (FDA) has taken formal steps to prevent and mitigate drug shortages for over a decade. While the problem predates the COVID-19 pandemic, the pandemic presented potential new challenges...more
In this week’s episode, Richard Church interviews Michael Hinckle about FDA inspections of health care providers. They discuss why an inspection might come up, what providers should expect, the do’s and don’ts of inspection...more
This final article in our four-part series examines other relevant laws digital health providers and suppliers should know. If you missed our earlier articles, you can read about HIPAA in Part I and Part II, and the FDCA and...more
This article examines another major regulatory regime relevant to mHealth application developers – the Federal Food, Drug and Cosmetic Act (FDCA), as well as regulatory issues unique to non-US companies. ...more
In Part I, we provided a high-level overview of Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its provisions. In Part II, we discuss how HIPAA is applied to mobile health (mHealth) application...more
Digital health technologies are revolutionizing the global health environment by advancing healthcare services, Big Data analytics and medical device development and innovation, expanding the reach, accessibility and...more
The Food and Drug Administration (“FDA”) recently published two policies related to the ongoing coronavirus (“COVID-19”) pandemic. First, on March 22, 2020, FDA published guidance “to help expand the availability of...more
A recent Federal Circuit court decision promises to significantly impact and broaden the scope of the types of foreign-produced pharmaceutical products companies can sell to the U.S. government.
...more
On January 31, 2019, the U.S. Department of Health & Human Services (“HHS”) issued a long-awaited proposed rule (the “Proposed Rule”) which, if finalized, would modify the discount safe harbor under the federal Anti-Kickback...more
2/12/2019
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
MCOs ,
Medicaid ,
Medicare ,
Medicare Part D ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Proposed Rules ,
Rebates ,
Safe Harbors
The U.S. Food and Drug Administration (FDA) recently released two draft guidance documents related to its requirement for shared risk evaluation and mitigation strategies (REMS) and the process for requesting a waiver of this...more
On November 6, 2017, U.S. Food and Drug Administration (“FDA” or “the Agency”) Commissioner Dr. Scott Gottlieb reiterated the Agency’s commitment to advancing medical device access and innovation by stating, “[o]ur goal is to...more
On October 13, 2017, the U.S. Food and Drug Administration (the “FDA”) announced in the Federal Register a notice of two upcoming public meetings and request for comments related to the initial phase of the Agency’s...more
Recent developments from the Trump administration relating to the 340B Drug Pricing Program (“340B Program”) could have a significant impact on covered entities, drug manufacturers, and others. In particular, the President’s...more
On March 20, 2017, the Health Resources and Services Administration (“HRSA”) published in the Federal Register an Interim Final Rule delaying the effective date of regulations relating to drug pricing and civil monetary...more
The European Union (“EU”) and the United States (“US”) have reached a sectoral agreement (the “Agreement”) that will greatly ease the administrative burden when proving compliance with Pharmaceutical Good Manufacturing...more
On January 5, 2017, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) issued a final rule on the calculation of drug ceiling prices under the 340B Drug...more
On August 12, 2016, the Health Resources and Services Administration (“HRSA”) released a notice of proposed rulemaking (the “Proposed Rule”) to formally regulate the administrative dispute resolution (“ADR”) process for...more
In an Opinion issued October 14, 2015, D.C. District Court Judge Rudolph Contreras granted Pharmaceutical Research and Manufacturers of America’s (“PhRMA”) motion for summary judgment against the U.S. Department of Health and...more
10/26/2015
/ Administrative Procedure Act ,
Affordable Care Act ,
Chevron Deference ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Healthcare Facilities ,
HRSA ,
Pharmaceutical Industry ,
PHRMA ,
Prescription Drugs ,
Section 340B
On June 16, 2015, the U.S. Department of Health and Human Services (“HHS”) and the Health Resources and Services Administration (“HRSA”) released proposed rules on civil monetary penalties and drug ceiling prices under the...more
6/24/2015
/ Affordable Care Act ,
Civil Monetary Penalty ,
Comment Period ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Healthcare ,
HRSA ,
Orphan Drugs ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation ,
Section 340B
On May 20, 2015, the Food and Drug Administration (“FDA”) proposed new regulations implementing the annual reporting requirements that were originally enacted by Congress in section 105 of the Animal Drug User Fee Amendments...more
On January 7, 2014, a three-judge panel of the United States Circuit Court for the District of Columbia unanimously vacated the dismissal of claims against the U.S. Food and Drug Administration (“FDA”) and others by K-V...more
In the fall of 2012, a meningitis outbreak sickened more than 750 people, killing 64 people and leaving many others with pain and nerve damage. The meningitis was traced back to tainted injectable steroids manufactured at a...more