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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FDA Documentation Insurance 119

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 57

The FDA Law Blog

NOVEMBER 11, 2024

Livornese & JP Ellison — On November 8, 2024, FDA issued a proposed order to remove the oral decongestant ingredient phenylephrine (including both phenylephrine hydrochloride and phenylephrine bitartrate) (collectively, PE) from the OTC monograph on the basis of a lack of effectiveness. By Deborah L.

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The FDA Law Blog

OCTOBER 13, 2024

A very important aspect of the program is that it costs FDA, and the government, no additional dollars, though we do not wish to minimize the additional resources a priority review demands over the standard review that such an application might otherwise receive. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

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Documentation FDA 62

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 Draft Guidance at 4.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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FDA Documentation Hospitals 57

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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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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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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FDA Medical Records Documentation 109

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 104

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

NOVEMBER 7, 2024

Upon receipt of the 513(g), FDA will assess whether the product meets the definition of a device under section 201(h) of the FD&C Act. Before FDA can begin its review of a 513(g) Request for Information submission, the applicant must pay the user fee. As an example, we filed a 513(g) request in December 2024.

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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 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 117

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 104

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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European Pharmaceutical Review

NOVEMBER 21, 2024

In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.

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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 57

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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Insurance Coverage Insurance Dosage Labelling 90

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

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

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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Controlled Substances Documentation Insurance Dosage 52

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

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

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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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 FDA Dosage Pharmaceutical Companies 52

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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Vaccines Packaging FDA Documentation 57

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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Health and Personal Care Stores Insurance Insurance Coverage Communication 85

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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Documentation Dosage Labelling 44

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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FDA Communication Documentation Labelling 57

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

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 Documentation Dosage 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