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. The final guidance provides additional discussion with respect to DHTs that meet the definition of a device.

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FDA Documentation 105

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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FDA Labelling 98

The FDA Law Blog

APRIL 3, 2023

Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). All of these products are line extensions under CMS’s definition. Vanda Pharmaceuticals, Inc. MJM-22-977 (Dist. times that of Medicaid ( $98 billion and $38.1

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Dosage 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

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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Dosage 59

BioPharm

SEPTEMBER 19, 2023

Maik Jornitz, Principal Consultant, BioProcess Resources LLC, discusses the definition of patient safety and how to implement new technologies into upgraded facilities.

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FDA 52

pharmaphorum

SEPTEMBER 30, 2021

Now, the FDA has published its first take on sourcing real-world data (RWD) from EHRs and medical claims, setting out its thinking on the approach that should be used to support regulatory filings for medicines. The FDA stresses it is a preliminary document and is encouraging comments, which can be filed up to 60 days after publication.

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FDA Documentation Insurance 95

pharmaphorum

OCTOBER 4, 2022

On 27th September 2022, the Food and Drug Administration (FDA) issued its final guidance for industry and FDA staff clinical decision support (CDS) software, which has been anticipated since the Center for Devices and Radiological Health (CDRH) listed the guidance as a top priority for fiscal year 2022. Criteria for regulation.

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FDA Documentation Labelling Communication 105

STAT

JANUARY 31, 2024

Ideally, he said, the FDA should be able to both stay on top of safety concerns and avoid unnecessarily restricting access to drugs. I think there are definitely situations for many drugs where you can say, no, we’re not really at the right balance, and the FDA should be taking a more aggressive stance in promoting patient safety.

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Adverse Reactions FDA Labelling Hospitals 118

pharmaphorum

SEPTEMBER 29, 2022

Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. a medical device subject to FDA oversight and enforcement.

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FDA Documentation 104

The FDA Law Blog

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable.

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FDA Documentation Labelling Communication 105

The FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. FDA further defined the term “protein” so that it includes any peptide product that has an amino acid sequence greater than 40 amino acids.

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FDA 95

The FDA Law Blog

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. Revised § 820.3

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FDA Labelling Packaging Documentation 59

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.”

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FDA 103

The FDA Law Blog

FEBRUARY 26, 2024

Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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FDA Dosage 59

STAT

FEBRUARY 13, 2024

In 2001, Gilead secured FDA approval of tenofovir disoproxil fumarate (TDF), one of first medicines to treat HIV — a product still on the market, despite the potential side effect of causing skeletal and kidney damage. Ultimately, this medicine was shown to have a better side effect profile than TDF.

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FDA 120

Pharmaceutical Commerce

MARCH 17, 2023

Industry is still scrambling to handle clerical errors of DSCSA transactions.

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FDA 52

The FDA Law Blog

MAY 6, 2024

Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. FDA provides examples of changes that are likely and unlikely to impact cybersecurity of an existing device.

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FDA Documentation 105

The FDA Law Blog

MAY 14, 2025

Schwartz In early April, Cellares became the first company to announce receipt of an Advanced Manufacturing Technology (AMT) designation from FDA. 356l), directed FDA to establish the AMT Designation Pilot Program. The law directed FDA to issue guidance regarding the implementation of the program, which was finalized in December 2024.

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FDA Communication 59

Pharmaceutical Technology

JANUARY 12, 2024

In an update, the FDA reported that it is yet to find a definitive association between GLP-1RA use and suicidal thoughts.

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FDA 52

The FDA Law Blog

JUNE 13, 2024

FTC, deep in its foray into the Orange Book, filed an Amicus Brief in the case arguing that the patents do not claim any FDA-approved drug. In other words, because FDA identified the drug “for which the applicant submitted the NDA” as “albuterol sulfate HFA Inhalation Aerosol,” albuterol sulfate must be claimed in the patent to be listable.

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Dosage FDA 116

Pharmaceutical Technology

OCTOBER 4, 2022

In May, Pfizer entered a definitive agreement to acquire all outstanding shares of Biohaven which were not previously held by the former. . Zavegepant, another CGRP receptor antagonist, is expected to receive approval as an intranasal spray from the FDA for the acute treatment of migraine in the first quarter of next year.

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FDA 106

The FDA Law Blog

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).

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FDA Labelling Communication 64

European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. Consequently, because “it calls into question the data integrity of the entire file”, FDA asserted that is unable to rely on the data to grant marketing authorisation.

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FDA Communication 104

The FDA Law Blog

MARCH 7, 2024

Now, FDA is granting a waiver of annual registration fees, per the draft guidance for Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance. FDA considers a “clear and objective standard” of financial hardship to be when a small business is in active bankruptcy.

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FDA 64

Pharmaceutical Technology

APRIL 17, 2023

SNBL has also signed a definitive agreement to acquire Satsuma Pharmaceuticals. In March 2023, Satsuma submitted a new drug application for STS101 to the US Food and Drug Administration (FDA). The company will begin a tender offer to buy all the common outstanding Satsuma shares for $0.91 in cash per share.

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FDA 59

The FDA Law Blog

OCTOBER 12, 2022

In light of the urgent public health need to facilitate and expedite access to naloxone, FDA is implementing this Guidance immediately without prior public comment. Because naloxone is a prescription drug, its distribution is subject to the requirements of the Drug Supply Chain Security Act (DSCSA).

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FDA Controlled Substances 52

The FDA Law Blog

OCTOBER 5, 2022

By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

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FDA Labelling Packaging Documentation 52

Pharmaceutical Technology

MAY 1, 2023

Astellas Pharma has entered into a definitive agreement to buy US-based biopharmaceutical company Iveric bio, in a deal valued at nearly $5.9bn. Under the deal terms, the company, through Astellas US Holding’s wholly owned subsidiary Berry Merger Sub, will acquire all the outstanding Iveric Bio shares for $40.00 in cash for each share.

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FDA 111

Pharmaceutical Technology

AUGUST 23, 2022

In July, the US Food and Drug Administration (FDA) accepted the New Drug Application resubmission of investigational lenacapavir for review. Earlier this month, the company entered a definitive agreement to acquire MiroBio for nearly $405m. A decision on the approval is anticipated by 27 December.

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FDA 119

The FDA Law Blog

FEBRUARY 22, 2023

Shapiro — More than a decade ago, FDA began systematically to incorporate review of human factors (HF) design validation within 510(k) reviews. Now FDA has issued a draft guidance , Content of Human Factors Information in Medical Device Marketing Submissions (Dec. FDA did not require HF data as a basis for clearance of the predicate.

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FDA Documentation Labelling Hospitals 64

ISPE

MAY 22, 2023

Regulatory speakers were Lisa Hedman, Group Lead for the Division of Supply and Access to Medicines of the World Health Organization (WHO); and Joyce Cirunay, Director IV of the Center for Drug Regulation and Research at the Philippines FDA. Joyce also emphasized the need for harmonization, especially for emerging economies.

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Communication FDA 98

The Checkup by Singlecare

DECEMBER 30, 2024

Sold under brand names such as Amvaz, Katerzia, Norliqva, and Norvasc , amlodipine is a medication that is FDA approved for the treatment of hypertension (high blood pressure), chronic stable angina (chest pain and pressure), vasospastic angina (coronary artery spasm), and coronary artery disease.

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Hospitals FDA 98

The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g.,

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Documentation Labelling FDA Packaging 59

pharmaphorum

FEBRUARY 17, 2022

The results come from a single-arm, unblinded study of the app, but add to the clinical evidence that EndeavorRx can have a positive impact on children with ADHD which led it to become the prescription game to be approved by the FDA in 2020.

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FDA 138

pharmaphorum

JANUARY 4, 2021

In the past, sponsors submitting to FDA were required to submit a PDF describing their submission datasets. FDA now requires that all submissions use Define-XML to describe their datasets. They don’t have a definition for what they want to submit, and so can’t verify if the submission data is what they intended.

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FDA 98

pharmaphorum

JUNE 12, 2022

bluebird bio started last week on tenterhooks, as FDA advisors cast their eyes over data for two gene therapy candidates that are key to its future as a commercially viable concern. The post Second unanimous FDA adcomm vote boosts bluebird bio appeared first on. Eli-cel was also previously approved in Europe as Skysona.

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FDA 59