The FDA Law Blog

APRIL 21, 2025

Butler Recent reductions in force (RIFs) and leadership changes at FDA are already affecting key agency functionsand as the administration plans a broader reorganization, the impact will likely grow. Thats all bad news if your timeline depends on FDA sticking to theirs. By John W.M. Claud & Michelle L.

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Documentation FDA 64

The FDA Law Blog

MARCH 31, 2025

That Rule sought to codify FDAs view that LDTs are medical devices subject to FDA regulation under the Food, Drug, and Cosmetic Act (FDCA) and then phase out, over a four-year period, FDAs purported policy of enforcement discretion for such tests. And Congress vested authority over those regulations in CMS, not in FDA.

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FDA 111

The FDA Law Blog

NOVEMBER 14, 2024

When the poet John Gay wrote these words in 1727, the idea of an administrative agency like the FDA was likely the furthest thing from his mind. That he is now being quoted in a blog post to discuss the relationship between medical device companies and their regulatory oversight body shows that some ideas really do have staying power.

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FDA 64

The FDA Law Blog

FEBRUARY 27, 2025

The American Conference Institutes popular FDA Boot Camp now in its 43rd iteration is scheduled to take place from March 19-20, 2025, at the NY Bar Association in New York, NY. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

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FDA 59

The FDA Law Blog

FEBRUARY 2, 2024

Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). This is to say nothing of the expected doubling of annual device submissions FDA expects it will then receive on an ongoing basis.

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FDA 116

The FDA Law Blog

MAY 27, 2025

By Dr. Naomi Lowy, Principal Drug Regulatory Expert FDA recently announced, CEO Forums: An FDA Listening Tour to Engage Pharma CEOs. and Director of FDAs Center for Biologics Evaluation and Research, Vinay Prasad, M.D., Importantly, final eligibility for attendance will be determined by the FDA.

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FDA 110

The FDA Law Blog

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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FDA 105

The FDA Law Blog

NOVEMBER 10, 2024

Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.

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The FDA Law Blog

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. FDA Law Blog readers can use discount code S10-866-866L24.S S for reduced registration fees.

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STAT

MAY 12, 2023

For an archived version of a live blog about Friday’s FDA advisory panel hearing, click here.

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FDA 98

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. However, in recent years, there has been a noticeable decline in the number of these letters being issued.

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PharmaShots

JUNE 11, 2025

Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals.

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FDA 52

PharmaShots

JUNE 13, 2025

Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals.

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FDA 52

The FDA Law Blog

DECEMBER 22, 2022

Koblitz — Back in June, when Congress was negotiating the User Fee Acts, FDA asked Congress to add in some provisions reversing several lawsuits that it had just lost. Ultimately, FDA lost that fight, and a slimmed down version of the FDA Safety and Landmark Advancements (“FDASLA”) passed without those sections.

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The FDA Law Blog

FEBRUARY 11, 2025

However, as we suggested in a recent blog post , the statute did not actually provide any limitations on FDAs authority to grant rare pediatric disease designations , only its authority to grant vouchers. In the meantime, the Pink Sheet confirmed that FDA was continuing to review rare pediatric disease designation requests.

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FDA 59

The FDA Law Blog

MAY 18, 2025

Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) launched a significant initiative called Operation Stork Speed to bolster the availability and safety of infant formula in the United States (see our previous blog post here ). Approximately two months later, HHS/FDA made good on their pledge.

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FDA 59

The FDA Law Blog

JUNE 2, 2025

Michael Laposata and the Association for Molecular Pathology in the recent LDT litigation, the Federal, Food, Drug, and Cosmetic Act does not authorize FDA to regulate LDTs as medical devices. Just before this decisive event, though, FDA released a relatively rare Warning Letter to a manufacturer of research use only (RUO) reagents.

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FDA Labelling 64

The FDA Law Blog

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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FDA Communication Documentation 111

The FDA Law Blog

OCTOBER 27, 2024

a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA. It’s a dessert topping; no, it’s a floor wax.

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FDA 100

The FDA Law Blog

MAY 15, 2025

FDA Law Blog readers are offered a discount of 10% off the registration price. The discount code is 25HYMAN10. You can access conference information and register for the event here.

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FDA 59

The FDA Law Blog

DECEMBER 15, 2022

By Riëtte van Laack — On December 7, 2022, FDA announced the availability of the final guidance regarding the enforcement policy for homeopathic drug products. This concludes FDA’s reevaluation of the regulation of homeopathic drugs which it started in 2015. FDA denied that petition in 2019.

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The FDA Law Blog

APRIL 3, 2025

Those decisions are changing the way agencies, including FDA, exercise their rulemaking and enforcement authorities. Either way, a revival of the nondelegation doctrine potentially introduces a number of constitutional issues for FDA, adding yet another limiting layer on agency authority.

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FDA 59

The FDA Law Blog

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. c) a submission of an IDE to the FDA is not required. c) a submission of an IDE to the FDA is not required.

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FDA Documentation 105

The FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” FDA also provided additional examples as to what changes would be considered “annual reportable.”

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FDA Documentation 105

The FDA Law Blog

JANUARY 5, 2025

Livornese As promised in the Fall Unified Regulatory Agenda, FDA issued the final rule to establish the pathway to obtain marketing approval of a nonprescription drug product with an additional condition for nonprescription use (ACNU) on December 26, 2024, before the end of the calendar year. By Deborah L. 105288 (Dec.

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Labelling FDA 59

The FDA Law Blog

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

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FDA Labelling 105

The 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). If FDA agrees to the PCCP, such changes can be made without a supplemental marketing submission.

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The FDA Law Blog

AUGUST 16, 2022

Farquhar — Those of us who work frequently on FDA inspections of drug and medical device manufacturing facilities have noticed an uptick in regular inspections after a dramatic falloff during the first two years of COVID. By Douglas B. Mr. Cruse pledged that the frequency of these inspections would increase.

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FDA 98

The FDA Law Blog

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. However, not all information contained in FDA records is disclosable.

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The FDA Law Blog

APRIL 7, 2025

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.

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FDA 59

The FDA Law Blog

APRIL 14, 2025

Baumhardt, Principal Medical Device Regulatory Expert In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).

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FDA Documentation 59

STAT

NOVEMBER 1, 2023

FDA staff said the new type of technology raised concerns about unintended genomic alterations that can potentially cause other side effects, but did not raise any concerns about efficacy. Read STAT’s live blog of yesterday’s advisory committee meeting here.

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FDA 108

STAT

JUNE 4, 2024

MDMA, commonly known as ecstasy or molly, is the first Schedule I psychedelic to be considered by the FDA — meaning that, if it’s approved, it would no longer meet the Drug Enforcement Administration’s Schedule I definition of having “no medical benefit. Follow the meeting on the live STAT blog here.

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FDA 106

The FDA Law Blog

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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The FDA Law Blog

MARCH 6, 2023

By Véronique Li, Senior Medical Device Regulation Expert — A year ago, we blogged about a proposed rule that would replace the Quality System Regulation (QSR) at 21 C.F.R. The proposed rule was published on February 23, 2022 and was first heralded by FDA in 2018 and introduced in the Spring 2018 regulatory agenda.

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FDA 105

The FDA Law Blog

NOVEMBER 6, 2023

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Significantly, FDA agrees that the RIEs may be conducted in lieu of an inspection. Raising the question: how does FDA define “all parties?”

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The FDA Law Blog

DECEMBER 12, 2022

Baumhardt, Senior Medical Device Regulation Expert — With the explosion of health‑related software, many software developers are generating products with functionality that is subject to regulation by the Food and Drug Administration (FDA). Please check out FDA’s presentation on this very topic – Is My Product a Medical Device?

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