FDA Law Blog

JUNE 28, 2022

This consolidated case has implications not only for prescribers of controlled substances but also for pharmacists and pharmacies who are subject to a “corresponding responsibility” to only fill prescriptions issued for a legitimate medical purpose pursuant to the Controlled Substances Act (21 U.S.C. § United States, No. 21 U.S.C. §

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FDA Law Blog

NOVEMBER 15, 2022

By Véronique Li, Senior Medical Device Regulation Expert & Philip Won — In our last blog post , we advised medical device companies to consider applying to FDA’s Small Business Program to help with the noticeably higher user fees for FY2023. In this blog post, we provide a primer on user fees and the Small Business Program.

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FDA Law Blog

SEPTEMBER 28, 2021

Richardson — On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 with the Pfizer-BioNTech COVID-19 vaccine. By Kalie E.

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FDA Law Blog

MARCH 4, 2024

This essential event for regulatory professionals in the biopharmaceutical and medical device industries will take place March 12-13, 2024, in Arlington, VA. FDA Law Blog readers can use the discount code 24SPKR150 for reduced registration fees.

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FDA Law Blog

FEBRUARY 20, 2023

This case was the latest example of government regulators punishing a company that refused to live up to its promises of consumer data protection. That’s a good list of the kinds of things that most consumers really do not want their digital medical services provider to do with their sensitive personal information.

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FDA Law Blog

OCTOBER 8, 2023

As a reminder, back in February 2023, HPM blogged about DEA’s two proposed rules for prescribing (1) controlled substances generally and (2) for buprenorphine use in opioid treatment. Temporary Rule: Second Temporary Extension of COVID–19 Telemedicine Flexibilities for Prescription of Controlled Medications, 88 Fed.

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ABIM

MAY 18, 2025

This burden of the disease is being felt by patients and healthcare providers. Without a full understanding of the disease context, he recommended surgery that, in hindsight, was not the medically appropriate next step. Worse yet, patients may avoid speaking up, even with their own providers, while suffering silently in pain.

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FDA Law Blog

OCTOBER 24, 2023

By Dara Katcher Levy — Yesterday, FDA published a new Draft Guidance, “ Communications from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers ” (SIUU Guidance or Draft Guidance).

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FDA Law Blog

MAY 7, 2025

Gonzalez There has been increased enforcement against medical device companies that engage in the pervasive practice of paying third party sales agents based on their volume of sales. Walsh & Sophia R. Gaulkin & Steven J. This scrutiny was enhanced after the Fourth Circuits ruling in United States v. Mallory , 988 F.3d

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FDA Law Blog

FEBRUARY 13, 2025

Baumhardt, Principal Medical Device Regulatory Expert FDA recently released its final guidance for Predetermined Change Control Plans (PCCPs) for Artificial Intelligence-Enabled Device Software Functions (AI-DSF). FDA provides definitions for the three datasets. Update practices and training of end users also need to be addressed.

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FDA Law Blog

JUNE 2, 2025

Mullen At midnight on Friday, May 30, 2025, the governments deadline to notice an appeal from the U.S. District Court for the Eastern District of Texass decision vacating the LDT Rule lapsed without the government doing so. By Steven J. Gonzalez & Allyson B.

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FDA Law Blog

JANUARY 12, 2025

Sasinowski On December 5, 2024, FDA published a new draft guidance on accelerated approval providing a much needed and substantial update to its guidance on the pathway. FDAs interpretation of several threshold criteria for eligibility (serious condition, available therapy, unmet medical need) will continue to rely upon the 2014 Guidance.

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FDA Law Blog

AUGUST 15, 2021

Shapiro — A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. FDA has now issued a final rule governing how intended use of a distributed product is to be determined. It is embodied in parallel drug and device regulatory definitions of intended use (21 C.F.R. §§ 201.128 (drugs), 801.4

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FDA Law Blog

OCTOBER 10, 2022

The CDS Guidance interprets the “medical software” carve-out of the 21st Century Cures Act (2016) as it pertains to Clinical Decision Support (CDS) software functions. Specifically, the guidance interprets the Cures Act’s four criteria for exclusion of CDS software functions from FDA’s medical device jurisdiction (so-called “Non-Device CDS”).

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FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R.

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FDA Law Blog

JANUARY 5, 2023

Claud — As we turn into the New Year, we offer a few items of interest in digital and telehealth regulation, enforcement, and compliance that may provide some helpful guideposts for stakeholders. Combination products are sharing the digital moment with those classified solely as medical devices. By John W.M.

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FDA Law Blog

MAY 19, 2025

For a controlled substance prescription to be effective, that is valid, it must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. Attorneys Office, Northern District of Illinois, April 21, 2025. Complaint, 82. 81, 86, 251. 81, 89, 251.

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FDA Law Blog

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Genus Medical Technologies secured an important victory in the D.C. In Genus Medical Technologies v. The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products.

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FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic also deeply impacted how industry and the government conduct their operations. However, not all changes are forever.

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FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. Once your request for an in-person or hybrid meeting is agreed upon, you are expected to provide a list of in-person and virtual attendees. Be ready with backup options (e.g.,

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FDA Law Blog

APRIL 10, 2025

federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. FOIA is a U.S.

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FDA Law Blog

OCTOBER 25, 2021

The Medical Device Amendments of 1976 created the initial premarket application (PMA) review and 510(k) substantial equivalence review processes. Only a year later, in 1977, FDA promulgated regulations governing 510(k) reviews (21 C.F.R. befitted a very important pathway to market for novel medical devices. Part 860.

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FDA Law Blog

JANUARY 31, 2022

The United States filed a Complaint against Texas entities Zarzamora Healthcare LLC, Rite-Away Pharmacy and Medical Supply #2– and its Pharmacist-in-Charge (PIC), and part owner. Because Plaintiff has provided no notice to defendants, the Court is precluded from issuing any preliminary injunction. 21 U.S.C. §

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FDA Law Blog

APRIL 4, 2023

The South Korean government has recently announced its plan to provide support for the growth of the nation’s biohealth industry, aiming to establish it as a significant and strategic sector in the nation, similar to the semiconductor industry.

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FDA Law Blog

APRIL 6, 2025

For nearly two decades, Dr. Lowy provided leadership across a range of important therapeutic areas, including general endocrinology, pain/opioids, cardiology, neurology, and psychiatry. We are excited by Naomis strong passion for solving complex regulatory issues and ensuring patient stakeholders have a voice in the drug development process.

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FDA Law Blog

AUGUST 8, 2024

Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. § 812(c)(c)(10).

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FDA Law Blog

NOVEMBER 6, 2023

Hyman Phelps & McNamara received the following honors: Tier 1 FDA: Pharmaceutical Tier 1 FDA: Medical Device Additionally, eight professionals are included in LMG’s coverage: Robert A. In addition, other law firms retain HPM to provide targeted expertise in food and drug law to assist their clients. Gibbs (Hall of Fame), John A.

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FDA Law Blog

FEBRUARY 5, 2024

HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.

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FDA Law Blog

AUGUST 4, 2022

The approval process, pre-approval concerns, product labeling, clinical trials, adverse events reports, patent concerns, and exclusivity – these are all critical aspects in the commercialization process for drugs and biologics that are governed by the FDA. UNDERSTAND the importance of cGMPs to the post-approval regulatory process.

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FDA Law Blog

FEBRUARY 4, 2024

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). By Steven J. Gonzalez & Gail H.

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FDA Law Blog

MAY 3, 2021

Recent Department of Justice (“DOJ”) press releases continue to show evidence of reported registrant civil settlements with the Government alleging recordkeeping and reporting deficiencies. Part 1 provides background and explains the scope of DEA cyclic and on-site inspections. 21 U.S.C. § 21 U.S.C. § 21 U.S.C. §

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FDA Law Blog

JUNE 22, 2022

This matter is the latest in a recent string of large monetary settlements between the government and health care providers involving employee diversion. Lax Controls Provided Employees with Opportunity to Divert. In short, the employees were provided the opportunity to not only commit the crimes but that they went undetected.

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FDA Law Blog

JANUARY 6, 2022

220 and was described on HP&M’s blog here. Clinical treatment facility” is defined as “a medical setting, other than a hospital, that provides detoxification, risk reduction, outpatient treatment and care, residential treatment, or rehabilitation for substance use, pursuant to licensure or certification under State law.”

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FDA Law Blog

JUNE 27, 2024

Alternating Between Cash and Insurance According to the government’s expert, patients paying for prescriptions with insurance and for others with cash is a red flag for those paid with cash. paid for some medications with insurance while paying for other controlled medications in cash, and Patient M.W. By Larry K. 21 U.S.C. §

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FDA Law Blog

MARCH 24, 2024

The 340B contract pharmacy dispute involves several manufacturers who are refusing to provide 340B discounts to covered entities if they requested 340B drugs to be delivered to, and dispensed from, a network of contract pharmacies. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.

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FDA Law Blog

MARCH 3, 2024

It remains to be seen whether FDA’s hasty finalization of the rule will provide fodder for APA challenges for failing to adequately address substantive comments. It seems very unlikely that FDA will have made significant revisions to the rule thereby resolving the issues raised by commenters. That hasn’t happened yet.

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FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. This program is modeled after a similar program in place for medical devices, the formal standards and conformity assessment program (S-CAP).

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