Omnicell

JANUARY 10, 2023

Stephanie Gallagher, PharmD, MBA Senior Clinical Product Marketing Manager, Omnicell Imagine if Amazon lost one out of every 10 packages. So why, as clinicians, are we not focused on improving the documented one in 10 inaccuracies in sterile compounded products? Or the airlines lost 10% of passenger bags.

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Sterile Compounds Compounding Omnicell Documentation 52

The FDA Law Blog

FEBRUARY 21, 2024

The long-awaited final rule, which we last discussed in a July 2023 blog post and have tracked in our March 2023 and March 2022 posts, aims to harmonize quality management system requirements for medical devices with requirements set forth by other regulatory authorities around the world. Notably, Part 820 will look different. The new § 820.10

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FDA Labelling Packaging Documentation 59

Impact Pharmaceutical Services

SEPTEMBER 28, 2023

There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.

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Documentation FDA Packaging 59

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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Packaging Labelling FDA Documentation 45

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. Meeting package content, timing of submission, and directions for submission are also covered by this Guidance.

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FDA Packaging Documentation 59

The FDA Law Blog

SEPTEMBER 27, 2023

The meeting package for Type D meetings should be included with the meeting request. FDA intends to provide preliminary responses to Type D meeting packages no later than 5 calendar days before the meeting date. The goal for meeting minutes is the same as all other meeting types – 30 days after the meeting.

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FDA Packaging Documentation 64

Impact Pharmaceutical Services

SEPTEMBER 20, 2023

If commercial, accessibility of cGMP API for proof of concept (POC) studies is much more possible in bulk in the open market, and may already be packaged in a suitable dosage form or strength for human trials. Repurposed commercial drugs also provide the advantage of having many patient years of reported safety data.

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Documentation Packaging Dosage Pharmaceutical Companies 59

Omnicell

JANUARY 10, 2023

Hospitals are already using Fresenius Kabi Simplist® MicroVault® prefilled syringes to help nurses spend less time preparing doses and documenting waste. The new cassettes for the Omnicell CSD will accommodate MicroVault® packaging for a variety of low-dose narcotic medications, including morphine, hydromorphone, and fentanyl.

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Controlled Substances Omnicell Hospitals Packaging 40

The FDA Law Blog

SEPTEMBER 26, 2022

FDA published a proposed list on June 13, 2018 (83 FR 27609), which we blogged about here. much like an FDA guidance document. FDA must also review the list periodically. The recent FR Notice does not modify § 4.4, but instead describes FDA policy on applying § 4.4, 880.6430 ).

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FDA Documentation Medication Dispensing Packaging 40

The FDA Law Blog

SEPTEMBER 6, 2023

Still, the document provides some guidance (naturally) as to materials required to submit a successful meeting request. And the Guidance may be used as leverage to secure action from FDA on a meeting request. The Guidance advises that the meeting request not be submitted until “significant progress” toward remediation has been made.

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FDA Packaging Documentation Labelling 45

The FDA Law Blog

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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FDA Packaging Documentation Communication 59

The FDA Law Blog

OCTOBER 5, 2022

Because it may not be possible to determine if processed foods meet the healthy claim criteria by analysis of the products, companies wishing to use a healthy claim may need to prepare documents to support the claim. FDA is conducting research on a symbol to represent the claim “healthy.”

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FDA Labelling Packaging Documentation 52

Roots Analysis

FEBRUARY 1, 2024

Further, the cold chain storage process involves the cold chain storage, cold chain transportation, and monitoring temperature controlled packaging products. Therefore, the pharmaceutical, biotech, food and chemical industries usually rely on cold chain packaging for the transportation of their products.

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Packaging Documentation Vaccines 40

Board Vitals - Pharmacist

NOVEMBER 8, 2022

Once clinicians have translated their research and skills into practice, they need to learn how to measure, quantify and document the outcomes data. appeared first on BoardVitals Blog. Developing and Evaluating Your EBM Educational Modules: BoardVitals Can Be Your Partner.

Medical Schools 52

Medical Schools Hospitals Packaging Documentation 52

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). iSpeak blog. iSpeak blog. BioPharm International. 2 October 2019.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

The FDA Law Blog

SEPTEMBER 30, 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., CMS’ final regulation expansively defines a “misclassification” to include not only misclassifying the drug category (e.g., Remarkably, manufacturers may not dispute a CMS notification.

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Vaccines Packaging FDA Documentation 59

The Thyroid Pharmacist

JULY 29, 2022

I was inspired to write this blog after the September 2020 Cameron Peak fires in Colorado. 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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Health and Personal Care Stores Compounding Immunization Labelling 52

The FDA Law Blog

APRIL 10, 2025

Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos.

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FDA Documentation Packaging Communication 59

The FDA Law Blog

DECEMBER 6, 2024

As much of the content of this draft guidance for cellular and gene therapy (CGT) products is articulated elsewhere, this document serves as a one-stop shop or Cliffs Notes for the numerous guidance documents now covering CGT product development. CBER will not commit to reviewing packages greater than 250 pages.

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FDA Documentation Packaging 59

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 ). However, given the similarities between these draft guidance documents, similar comments may be expected.

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Labelling FDA Documentation Packaging 52