The FDA Law Blog

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). FDA recognizes the potential of RWE to support regulatory submissions of medical devices and to inform benefit-risk analysis of such products, while assuring patients have timely access to devices.

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The FDA Law Blog

OCTOBER 16, 2023

Can the FDA Keep them Safe”—focuses on FDA’s role in regulating clinical applications of AI/ML technologies and the impact of FDA’s regulatory requirements on the type of products developers choose to bring to market and how quickly they can be improved once there. demographic bias of data fed to algorithms).

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Documentation FDA 119

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Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.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

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents.

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FDA Documentation Labelling Communication 105

The FDA Law Blog

SEPTEMBER 24, 2024

Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. 13, 2024). By Deborah L.

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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. FDA further retained some definitions in the QSMR. The new § 820.10 Revised § 820.3

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FDA Labelling Packaging Documentation 59

The FDA Law Blog

FEBRUARY 28, 2024

This is the third withdrawal of an accelerated approval FDA has performed, following Avastin in 2011 and Makena in 2023. Without commenting on the merits of the decision, it is an interesting window into how FDA may use these new procedures in practice. Tobolowsky & Michelle L.

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European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs. MHRA announced that it will publish its guidance in 2024.

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Documentation FDA 105

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

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The FDA Law Blog

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. For example, FDA granted seven De Novos for COVID-19 related indications for use. In effect, these documents serve as road signs helping to direct new market entrants.

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The FDA Law Blog

OCTOBER 2, 2024

As a reminder, a PCCP is a document submitted in a marketing application that describes future modifications to a device that would typically require submission of a subsequent application and a description of how the sponsor will verify and validate the modified device. Draft Guidance at 4. Change Guidance at 8.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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Independent Pharmacies FDA Documentation CPhT 52

The Checkup by Singlecare

AUGUST 3, 2024

Latuda (lurasidone) is a brand-name prescription drug that’s approved by the Food and Drug Administration (FDA) to treat schizophrenia as well as bipolar depression associated with bipolar I disorder. In 2019, the FDA approved a generic version of Latuda (lurasidone) , which just became available in 2023.

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European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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The FDA Law Blog

AUGUST 7, 2023

Submit proposal documents by email to ELP Proposal Submissions by September 5, 2023 at 12 PM ET. As a former participant, it was beneficial to me to engage with companies in person at their place of business and see the equipment used in manufacturing the medical devices that are reviewed by FDA. Identify the site visit duration.

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The FDA Law Blog

DECEMBER 12, 2024

4, 2024), at 1. The parties have noticed their intentions to offer into evidence documents they identified in their prehearing statements and must serve each other with a copy of the documents noticed in their prehearing statements no later than January 3, 2025. Prehearing Ruling (Dec.

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Controlled Substances Documentation 52

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

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Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis. Fighting Entresto generics.

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pharmaphorum

JANUARY 21, 2021

It can be prescribed in combination with methotrexate or as a monotherapy if the patient isn’t able to receive methotrexate, according to the final appraisal document (FAD). Gilead will receive royalties on European sales from 2024, and retains commercial rights elsewhere.

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DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. To achieve this, the U.S.

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Independent Pharmacies Packaging Documentation FDA 40

The FDA Law Blog

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. 50,372 , 50,377 (June 13, 2024). Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 at 50,372-73.

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The Checkup by Singlecare

APRIL 5, 2024

When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Important note: Like Mounjaro, many of these drugs are in demand—and as of early 2024, some are in short supply, so they could be difficult to get.

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ISPE

JULY 6, 2023

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Since then, agencies have begun officially adopting the guidance, with the FDA doing so in March 2023.

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The Checkup by Singlecare

MAY 1, 2024

The FDA has approved these devices for mild to moderate hearing loss. In 2024, the household income limit to qualify is under $27,180 for an individual or under $36,620 for a two-person household. In 2024, this is $30,120 for an individual and $40,880 for a couple. There are a few options to consider.

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The FDA Law Blog

JUNE 16, 2023

Initial appointments to both the Board and advisory council will occur by January 1, 2024. Prescription Drug Affordability Board The law also establishes a nine-member Prescription Drug Affordability Board and an 18-member stakeholder advisory council to provide advice to the Board on drug cost issues.

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ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. Results from each part will be presented periodically at ISPE meetings throughout 2023 and 2024. www.fda.gov/about-fda/oncology-center-excellence/project-orbis. 22 June 2023. 22 June 2023. EMA/321483/2020. 3 July 2020.

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STAT

FEBRUARY 28, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. The … A much-anticipated inquiry by U.S.

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pharmaphorum

JUNE 10, 2022

The FDA may have safety concerns abut bluebird bio’s gene therapy for rare, fatal disease cerebral adrenoleukodystrophy (CALD), but its advisors believe its benefits far outweigh the risks. bluebird is also conducting the phase 3 ALD-104 trial of eli-cel in CALD, which is due to generate results in 2024.

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OctariusRx

MAY 13, 2024

Our 2024 nursing calculations quiz is now available. Food and Drug Administration (FDA) receives more than 100,000 reports associated with a suspected medication error. Since medications are usually dosed milligrams per kilogram, learn to consistently convert and document the patient’s weight in kilograms. Each year, the U.S.

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The Checkup by Singlecare

MARCH 10, 2025

The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Some insurance plans may cover Ozempic for managing Type 2 diabetes , which is an indication that is approved by the Food and Drug Administration (FDA) to treat. Does insurance cover Ozempic?

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Compounding Insurance Insurance Coverage FDA 52

The FDA Law Blog

JULY 9, 2024

To encourage the development of such guidance, Congress directed FDA to issue a draft guidance not later than 12 months after the date of FDORA’s enactment and to finalize such guidance not later than 9 months after closing the comment period. intended use population. population in light of the U.S. role in global health.

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The FDA Law Blog

SEPTEMBER 30, 2024

Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 2024. Yet another rejection was a proposal requiring a diagnosis on Medicaid prescriptions as a condition for claims payment. The most noteworthy are the following: 1.

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ISPE

SEPTEMBER 8, 2023

Attendees were invited to submit questions to the FDA representatives. Please note that views expressed by the panelists are not necessarily representative of the position of the FDA, and that questions and responses are lightly edited for clarity. How will the FDA use Annex 1 in its final version?

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The FDA Law Blog

JANUARY 13, 2025

Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and Cosmetic Act This final guidance replaces previous draft and final guidance documents on food allergen labeling that FDA issued in November 2022, which we discussed in a previous post. By Sophia R.

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The FDA Law Blog

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).

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FDA Documentation Labelling 105

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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The FDA Law Blog

JANUARY 30, 2025

Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study.

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