The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

FDA

ISPE

MAY 11, 2023

The key to data integrity compliance is a well-functioning data governance system 1 , 2 in which the data flow path for all business processes and equipment—such as in manufacturing, laboratory, and clinical studies—is fully understood and documented by a detailed process data flow map. Many organizations already have documented process maps.

Packaging

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation

ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” If elements such as these are adopted during the revision of ICH M4Q, this could influence global regulatory agencies to eliminate the requirement for custom Module 2 commitment documents. The authors propose using Module 2.3 Published 15 November 2021.

Documentation

European Pharmaceutical Review

JANUARY 13, 2025

5 However, the benefits are well documented. If we want to lead the way in green innovation and show that the UK is open for business, we need a broader definition and recognition of innovation. 6 Thinking beyond the propellant, approaches to sustainable respiratory care require holistic thinking as it is a delicate balancing act.

Packaging

DiversifyRx

JULY 11, 2024

To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request. Identifiers All products received must contain a product identifier. For additional information on identifying full-time employees, see [link].

Independent Pharmacies

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.”

FDA

Hospital Pharmacy Europe

JULY 3, 2024

The process of safeguarding In healthcare, the initial safeguarding process comprises four stages: recognition, ensuring patient safety, documentation and escalation. The description and definition of Emergency Department Pharmacist Practitioners in the United Kingdom (the ENDPAPER study). Pharm J; 26 March 2024. Greenwood D et al.

Hospitals

PQA

JUNE 27, 2024

Pilot participants were provided a technical package containing all resources needed to accurately calculate the SP-TAT-PH measure. Barriers to Optimizing TAT Prior authorizations are often responsible for longer TAT, with many participants expressing the burden of rigorous documentation required by payers.

Specialty Pharmacies

ISPE

MARCH 15, 2023

4 The biopharmaceutical industry is taking steps to increase its environmental sustainability, 5 which begins with identifying and testing alternatives to existing procurement, materials, logistics, equipment, services, manufacturing processes, packaging, and facility design 6 (see Table 1). 7 An integrative (vs. 7 An integrative (vs.

Packaging

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. -ft. cold room, 27,500 sq.

FDA

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., 16 Health Canada.

Documentation

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.

Packaging

The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. that is not supported by the statute and applicable regulations.” 1396r-8(k)(3).

Vaccines

Board Vitals - Pharmacist

NOVEMBER 8, 2022

Bench to bedside: In its definition, the National Institute of Health characterizes EBM as “the intersection of research, evidence and clinical practice.” Step 1: Problem definition Remember how Dr. Evans and his care team observed a persistent incidence of secondary issues among patients admitted with fractured hips?

Medical Schools

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). These new operating models can help enable and accelerate the efforts of Pharma 4.0™

Health and Personal Care Stores

ISPE

JULY 6, 2023

Continuous Manufacturing: Definitions and Engineering Principles,” in Continuous Manufacturing of Pharmaceuticals, pp. The quality mindset has grown, with a clear definition of the boundaries of a batch. “Economic Analysis of Integrated Continuous and Batch Pharmaceutical Manufacturing: A Case Study.” 17 (2011):10083–92.

HIV Treatment and Prevention Agents

The FDA Law Blog

JANUARY 20, 2025

Nearly two years after FDA issued draft guidance on Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements , on January 6, 2025, FDA released draft guidance document on plant-based labeling, Labeling Plant-Based Alternatives to Animal-Derived Foods. Comments on the draft guidance may be submitted until May 7, 2025.

Labelling

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.

FDA