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. Notably, Part 820 will look different. Revised § 820.3

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The Checkup by Singlecare

JANUARY 11, 2024

As a pharmacist, it’s always a good idea to stay in the know on upcoming FDA approvals. As the new year begins, industry professionals are closely monitoring the Food and Drug Administration (FDA) calendar for decisions that could bring new drugs to the market. and hepatic fat by up to 38.6% over 52 weeks, compared to a placebo.

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Pharmaceutical Technology

MAY 25, 2023

Celltrion USA has received approval from the US Food and Drug Administration (FDA) for Humira (adalimumab) biosimilar, Yuflyma (adalimumab-aaty) , for multiple indications. Yuflyma represents the company’s fifth biosimilar and second anti-TNF biosimilar to receive US FDA approval.

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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? affected by a shortage).

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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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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

SEPTEMBER 15, 2022

The Massachusetts-based biotech said it a meeting with the FDA to discuss the programme has given it the confidence to press ahead with filing for approval of the RASP modulator in the US later this year. The post Aldeyra spies FDA filing ahead for dry eye drug reproxalap appeared first on. Image by StockSnap from Pixabay .

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European Pharmaceutical Review

AUGUST 26, 2024

The concentration of the formulation means the treatment can be administered ocularly via eye drops packaged in single-dose containers, according to SIFI. Akantior was granted Orphan Drug Designation from the US Food and Drug Administration (FDA) to treat acanthamoeba keratitis.

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The FDA Law Blog

MARCH 3, 2024

3558 ) on January 25, 2024. Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update? House of Representatives ( H.B. 7085 ) and Senate ( S.B.

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The Checkup by Singlecare

JANUARY 7, 2025

In 2023, the Food and Drug Administration (FDA) reported that phenylephrine was ineffective. The FDA followed this up in 2024 by proposing that products like DayQuil Cold and Flu stop using phenylephrine. While it may be acceptable to take DayQuil with amoxicillin, these FDA reports could make one wonder whether it is worth it.

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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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The Checkup by Singlecare

FEBRUARY 11, 2025

Repatha is the brand name for evolocumab, an FDA-approved monoclonal antibody used to lower cholesterol. Common side effects of Repatha According to data from the FDA, based on clinical trials, the most common side effect of Repatha is nasopharyngitis, which is inflammation of the nasal passages and throat.

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The Checkup by Singlecare

MARCH 21, 2024

Its active ingredient, semaglutide, is FDA approved for weight loss under the brand name Wegovy , which has a dosing progression of 0.25 has said they expect the shortage to last at least until March 2024. The limits for 2024 are $22,590 for individuals and $30,660 for married couples. mg, 1 mg, 1.7 mg, and 2.4

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The FDA Law Blog

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). Notably, the purpose of the statute seemed to govern much of FDA’s interpretation.

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Pharmaceutical Technology

JULY 29, 2022

This data has been shared with regulators, including the US Food and Drug Administration (FDA), and a request for US Emergency Use Authorisation (EUA) is planned. The EMA started a rolling review for this Omicron-adapted vaccine on 27 June and the FDA plans to review the vaccine for EUA. The expansion will be operational in 2024.

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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 tracking involves the use of unique product identifiers, such as serial numbers and barcodes, on drug packaging to track their movement.

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Roots Analysis

AUGUST 1, 2024

Some of the GLP-1, namely Trulicity®, Mounjaro®, Zepbound®, Feisumei®, Rybelsus®, Ozempic®, Wegovy® were approved for the treatment of various target indication, by the US FDA and the EMA. per package in the US. Examples of some partnerships in this domain include: In May 2024, Sciwind Biosciences and HK inno.N

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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. Samples often come in a package of four 2.5 And it’s not just hype. mg single-use pens, a one-month supply.

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European Pharmaceutical Review

MARCH 28, 2024

FDA is expected to provide initial feedback on the data submitted by July 2024, with further data to be collected and analysed over the next two years. What is the main reason submission of the DVA qualification to FDA is significant for future clinical trials?

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The Checkup by Singlecare

MARCH 7, 2024

It was approved by the Food and Drug Administration (FDA) in 2017 for treating Type 2 diabetes. In fact, many credible online platforms selling Ozempic only do so as part of a membership package, which actually increases your overall costs. Makhija explains, as the generic version is not FDA approved.

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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. The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g.,

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PharmaShots

MARCH 1, 2023

osteoporosis in postmenopausal women and men with high fractures risk, treatment-induced bone loss The submission was based on the comprehensive analytical and clinical data package, incl. Under the co-development agreement, Similis Bio & Novel351k is expected to be valued at $100M incl. development milestones and royalties for ~10yrs.

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IDStewardship

JANUARY 13, 2025

BCIDP UNDER CONSTRUCTION Article PostedXXX Sulopenem etzadroxil and probenecid (Orlynvah) was recently approved in October 2024 for the treatment of uncomplicated urinary tract infections (uUTI) caused by Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis. 2024 Nov 2:S1198-743X(24)00507- X. Orlynvah [package insert].

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The FDA Law Blog

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Section #1: FDA Interactions Given the wide range of sponsors (i.e., The draft guidance recommends that no more than 15 questions are included in the briefing package.

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European Pharmaceutical Review

APRIL 2, 2025

11-13 Recent reports from US Food and Drug Administration (FDA) authors concluded that AI can usefully be applied to some aspects of ICSR (individual Case Safety Reports) processing and evaluation, but the performance of current AI algorithms requires a human-in-the-loop to ensure good quality. 2024 [cited 2025Feb]. 2024 ;234:3418.

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The FDA Law Blog

DECEMBER 11, 2024

Karst We learned earlier this week that an allision (a runner-up to Merriam-Websters 2024 Word of the Year, polarization) may be poised to occurperhaps within a fortnight (another runner-up to Merriam-Websters 2024 Word of the Year thanks to Taylor Swift)as Congress considers various pieces of healthcare legislation as part of its year-end package.

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