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).

Documentation 119

Documentation FDA 119

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

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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Documentation Insurance FDA 40

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 92

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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FDA Documentation 59

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 52

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

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FDA Documentation Method Validation Packaging 89

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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FDA Vaccines Documentation 52

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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FDA Documentation Labelling 59

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.

Health and Personal Care Stores 52

Health and Personal Care Stores Insurance Insurance Coverage Communication 52

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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Dosage Documentation Labelling 45

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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Documentation Dosage FDA Pharmaceutical Companies 52

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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Insurance Compounding Pharmacies Compounding Insurance Coverage 59

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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Documentation Labelling FDA Hospitals 52

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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FDA Dosage Documentation Communication 52

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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Documentation FDA Hospitals Dosage 97