The FDA Law Blog

MARCH 5, 2023

Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. FDA may deny a PSG if the applicant’s bioequivalence testing started after the PSG publication.

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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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Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

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Impact Pharmaceutical Services

AUGUST 9, 2022

Over the next year, IMPACT authored the following documents for the client: Pre-NDA meeting package. Working with the company’s electronic publishing vendor to ensure that fully-compiled, submission-ready documents were produced. 5 clinical study reports. and 2.7.4), and the Clinical Overview (Module 2.5).

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The Checkup by Singlecare

FEBRUARY 23, 2024

Wegovy is a brand-name medication approved by the Food and Drug Administration (FDA) for weight loss in certain patients, including children 12 and older. per package, which is equivalent to about $16,188 per year. It should be used together with a reduced-calorie diet and increased physical activity. How much does Wegovy cost?

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European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

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The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.

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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. Notably, Part 820 will look different. The new § 820.10

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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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pharmaphorum

JANUARY 18, 2022

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. Secondary packagers.

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The Checkup by Singlecare

MARCH 6, 2023

“However, since children’s dosing recommendations may vary between Benadryl products, it’s best to check the package label for dosing instructions to ensure appropriate and safe dosing,” says Dr. Johnson-Arbor. Dosing for the topical versions of Benadryl will differ, so always follow package instructions or consult your healthcare provider.

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Impact Pharmaceutical Services

AUGUST 9, 2022

Hosted software to publish regulatory submissions in the electronic common technical document (eCTD) format was deployed. The group successfully submitted a “pilot” eCTD submission to the Food and Drug Administration (FDA) and gained FDA approval to transmit submissions through the Electronic Submissions Gateway (ESG).

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The FDA Law Blog

SEPTEMBER 27, 2023

The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA. Tobolowsky — Much has changed since the long-gone days of 2017.

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European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

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The FDA Law Blog

MARCH 27, 2023

Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.

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ISPE

JANUARY 11, 2023

For example, the equipment for blending and packaging large-volume, high-viscosity formulations is complex, and the residues can be challenging to remove. Returning to a development process within the execution of a validation protocol can come with complexities in documentation and regulatory compliance.

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The FDA Law Blog

SEPTEMBER 26, 2022

Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). FDA must also review the list periodically.

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Pharmaceutical Technology

MARCH 30, 2023

Earlier in March, the FDA shared a draft guidance on how to run clinical trials for the accelerated approval of cancer drugs. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

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Pharmaceutical Technology

SEPTEMBER 23, 2022

And, because it also manufactures products, its staff is current on regulatory requirements and FDA/ICH Guidance documents. Fully integrated development and manufacturing partners can minimise the impact of delays, improve overall efficiency, as well as minimising FDA information requests to enable a faster approval cycle.

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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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ISPE

MARCH 7, 2023

The chosen CxP focused on finding solutions and resolving issues instead of only documenting problems, which proved beneficial in turning over fully functional and highly integrated facilities for critically complicated projects already within the company’s portfolio. To infinity and beyond, indeed.

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The Checkup by Singlecare

FEBRUARY 16, 2024

“Antioxidant” has become a hyper-common wellness buzzword, slapped on health food packages so often that many people don’t think twice about it. 10 potential health benefits of NAC Some of NAC’s uses are time-tested and well-documented, like its efficacy in treating acetaminophen overdose.

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pharmaphorum

AUGUST 16, 2021

Thankfully, paper-based studies are becoming a thing of the past, but spreadsheets and Word documents are still commonly used to design and build trials. These are now used by several regulatory bodies, including the Food and Drug Administration (FDA) and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for submission packages.

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ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel. In the fourth and last step, the defined work packages are executed. to Industry 4.0

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ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

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ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.”

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ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 9 In 2015, the FDA published a guidance manual 10 that provided questions for inspections, including: Is the air flow in critical areas unidirectional when delivered to the point of use? m/s up to 0.54 At what velocity?

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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ISPE

AUGUST 30, 2022

In this article, the term “raw material” refers to a material used in the manufacturing and packaging of a drug substance (DS) or a drug product (DP). Finally, the DP is packaged in a suitable container to ensure continued quality. It is considered a moderate change by the FDA (CBE30) and NMPA.

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ISPE

JULY 6, 2023

As of 2022, there were 15 drugs (see Table 1) manufactured using CM elements that have received FDA approval, with GSK, Pfizer, and Vertex owning approximately 60% of the market share, followed by Janssen/J&J with about 13%. Table 1: List of FDA-approved commercial products using CM elements.

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Pharmaceutical Technology

APRIL 26, 2023

Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.

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The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Feel free to use my own health timeline as a guideline to document your health journey. Most filter manufacturers have pictures on their filter packaging that indicate what they will and will not filter, along with the MERV rating.

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