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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pharmaphorum

SEPTEMBER 21, 2022

The European Commission has followed the lead of the US FDA and approved AstraZeneca’s Tezspire as an add-on maintenance therapy for patients with severe asthma, becoming the first and only biologic that can be used in all patients, and not restricted to those with specific forms of the disease. billion or more.

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Labelling FDA 111

pharmaphorum

JUNE 6, 2022

The results have set up a pre-filing meeting with the FDA, according to BMS. Rozlytrek was approved by the FDA in 2019 but has just started to gather sales momentum, making around $17 million in the first quarter of this year, an increase of 78% on the first three months of 2021.

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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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Pharmaceutical Technology

JUNE 7, 2023

Mounjaro’s approval for obesity, particularly in the US and EU markets, means the drug is entering a significantly large market where it will have direct competition from Novo Nordisk’s Wegovy (semaglutide), which is currently the leading glucagon-like peptide-1 (GLP-1) therapy approved for obesity by both the FDA and EMA.

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The FDA Law Blog

JULY 7, 2024

Unfortunately, the guidance for small entities recently published by FDA is little more than a summary digest of the multi-hundred-page final rule. However, the guidance provides no new information on how FDA expects laboratories to implement these new requirements. 803), Reporting of Corrections and Removals (21 C.F.R. § 820.198).

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Labelling FDA Communication Documentation 64

The Checkup by Singlecare

MARCH 31, 2025

Ozempic is the brand name for semaglutide, which is a medication thats FDA approved to treat high blood sugar in people with Type 2 diabetes. It is also often prescribed off-label as a weight loss medication, even in patients with normal blood sugars.

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The FDA Law Blog

OCTOBER 24, 2022

355g(a), directed FDA to “establish a program to evaluate the potential use of real world evidence” both “to help to support the approval of a new indication” and “to help to support or satisfy postapproval study requirements.” The sponsor and FDA reach agreement on the study design information to be publicly disclosed.

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pharmaphorum

OCTOBER 26, 2022

The drug was highlighted at Boehringer’s R&D update earlier this year as one of the most promising candidates among 15 new medicines it plans to bring to market by 2025, fuelled by a €25 billion R&D spend. billion a 25% gain in the prior year and fuelled in part by extensions to its label to include other progressive ILDs.

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Pharmaceutical Technology

APRIL 21, 2023

On 14 April, the FDA rejected Lilly’s biologic licence application (BLA) for their anti-interleukin (IL)-23, mirikizumab, which is in development for the treatment of ulcerative colitis (UC). The recent setback dents mirikizumab’s chances to be the first among the IL-23 inhibitors to launch in the US for UC.

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pharmaphorum

NOVEMBER 30, 2021

The FDA has kicked off its review of Bristol-Myers Squibb’s psoriasis therapy deucravacitinib, setting an action date of 1 September next year, as the EU and Japanese regulators also start their appraisals of the drug. The post FDA sets Sept review date for BMS’ psoriasis drug deucravacitinib appeared first on.

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The Checkup by Singlecare

JULY 2, 2024

Mounjaro is a popular brand-name medication approved by the Food and Drug Administration (FDA) to improve blood sugar control in people with Type 2 diabetes, along with diet and exercise. One common side effect of Mounjaro is weight loss, which is why it may sometimes be prescribed off-label (for a non-FDA-approved use) for that purpose.

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pharmaphorum

SEPTEMBER 11, 2022

The US FDA has cleared the first-in-class tyrosine kinase 2 (Tyk2) inhibitor as Sotyktu , and BMS says it now plans to launch the new drug later this month, aiming to mount a challenge to Amgen’s $2.3 billion oral psoriasis therapy Otezla (apremilast).

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The FDA Law Blog

JULY 6, 2023

Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), during his remarks at the annual Food Drug and Law Institute (FDLI) conference in May 2023. In fact, the priority designation for the final rule is labeled as “economically significant.”

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The FDA Law Blog

OCTOBER 24, 2023

Mullen — As of October 1, 2023, all 510(k) submissions, unless exempted, must be submitted to FDA using the electronic Submission Template And Resource ( eSTAR ). Currently, eSTAR is voluntary for medical device De Novo submissions, but FDA has initiated the process of requiring De Novos to be submitted using eSTAR. 860.230.

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The Checkup by Singlecare

MARCH 21, 2024

The drug and its fellow SGLT2 inhibitors, Farxiga (dapagliflozin), Invokana (canagliflozin), Steglatro (ertugliflozin), and Brenzavvy (bexagliflozin), are approved by the Food and Drug Administration (FDA) for treatment of Type 2 diabetes. Although there is no generic version of Jardiance available currently, there may be as early as 2025.

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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European Pharmaceutical Review

MARCH 14, 2024

For IgA nephropathy (IgAN), key highlights include the US Food And Drug Administration (FDA) approval of Calliditas Therapeutics’ TARPEYO and the Committee for Medicinal Products for Human Use (CHMP)’s recommendation of a conditional marketing authorisation for Filspari (sparsentan).

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The Checkup by Singlecare

FEBRUARY 10, 2025

Food and Drug Administration ( FDA ) in 2014 for Type 2 diabetes. Since then, its FDA -approved uses have expanded, now including kidney disease, heart failure , and Type 2 diabetes. As of January 2025, only the Prasco version of dapagliflozin is available in pharmacies.

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pharmaphorum

AUGUST 9, 2022

Tagrisso meanwhile has been FDA-approved as a second-line treatment for EGFR T790M mutation-positive NSCLC since 2015, with its label extended since then to include first-line and adjuvant treatment. It is AZ’s biggest-selling drug, with sales topping $5 billion last year.

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PharmaShots

MAY 3, 2023

The results showed that CT-P42 met the predefined equivalence criteria of ±3 letters, and 2EPs of efficacy, safety, and immunogenicity also showed similar trends to Eyela Eylea is expected to reach substance patent expiration in the US in June 2023 and in the EU in May 2025. Infections were observed in 33.9%

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The Checkup by Singlecare

OCTOBER 9, 2024

While Lumigan is a 0.01% solution of bimatoprost and no generic product is manufactured at this concentration, patents on Lumigan expire in 2025 and 2027, so there may be a generic option approved by the Food and Drug Administration (FDA) thereafter. Generic bimatoprost drops are available at a 0.03% concentration currently.

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The FDA Law Blog

JANUARY 23, 2023

Livornese — Last month, Congress took a big step towards improving clinical trial diversity by requiring sponsors of most drug and device clinical studies to submit a diversity action plan when they submit key trial documents to the Food and Drug Administration (FDA). This guidance was finalized in 2020.

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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. Sponsors may discuss DAPs with FDA sooner. intended use population. role in global health.

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FDA Communication Documentation Labelling 59

ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products.

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ISPE

OCTOBER 27, 2022

In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products.

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Health and Personal Care Stores FDA HIPAA Communication 52

IDStewardship

DECEMBER 11, 2024

I wonder if this will cause us to be more fragmented as a group in 2025 and if Bluesky will really have sticking power. With Twitter changing to X in mid-2023 and subsequently in the end of 2024 many folks from the IDtwitter community moving over to Bluesky, the game is certainly ever-changing. Mastodon sure did not.

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The FDA Law Blog

JANUARY 20, 2025

Gaulkin & Ritte van Laack Readers of this blog likely are familiar with the ongoing, often contentious battle over the labeling of plant-based foods (see, e.g., here , here , and here ). non-standardized foods), their labeling must bear the common or usual name of the food, if such a name exists.

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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 14, 2025

The passing of the law which, among other things, amended the Federal Food, Drug, and Cosmetic Act to include requirements for facility registration and product listing, safety substantiation, adverse event reporting, and requirements for FDA to issue several new regulations, brought excitement and anxiety. Just on the cusp of 2024, on Dec.

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The FDA Law Blog

MARCH 30, 2025

Livornese & Ricardo Carvajal On March 18, 2025, the U.S. 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 ( link , link ). By Charles D.

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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. The reality is that FDA simply does not prioritize 513(g) requests.

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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

JANUARY 2, 2025

By Ritte van Laack As we previously reported in 2022, FDA published a proposed rule defining the nutrient content claim healthy. In contrast, the 2022 proposed redefinition focused on food groups recommended by nutrition science and the Dietary Guidelines (DGs), 2020-2025. The final rule maintains the concept of the proposed rule.

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The Checkup by Singlecare

MARCH 26, 2025

Kaisers 2025 Comprehensive Formulary documents for commercial insurance and Medicare Part D show which drugs their plans will generally cover, as long as theyre medically necessary. Per Kaisers 2025 Comprehensive Formulary , Ozempic is typically in tier 3, so youll likely still have some out-of-pocket costs. Does Kaiser cover Ozempic?

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The FDA Law Blog

MARCH 6, 2025

We were struck by the level of detail expected by FDA for processes related to data management, especially for data collected and used early in development to train an initial AI model, which may occur before a manufacturer decides to move forward with device development under design controls. By Adrienne R.

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The FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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