European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents.

Labelling 98

Labelling Documentation 98

The FDA Law Blog

OCTOBER 26, 2022

To date, neither side has sought to take the issue to the mat in a way that would definitively resolve the dispute. to take photographs as necessary; to collect samples; talk to pertinent staff; or to collect food labels and labeling).

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FDA Labelling Documentation 59

European Pharmaceutical Review

JULY 4, 2024

However, as with drugs, dietary supplements require evidence that they are safe and that claims on product labels are truthful and not misleading. It begs the question of why only two botanical drug products have obtained FDA approval and fulfilled the Botanical Guidance definition of a botanical product.

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FDA Documentation Compounding Pharmaceutical Companies 103

The FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. as a de novo special control or in a guidance document for a specific device type).

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FDA Documentation Labelling Hospitals 64

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 52

Independent Pharmacies FDA Documentation CPhT 52

The FDA Law Blog

OCTOBER 11, 2022

Even in the absence of a guidance document dedicated to explaining FDA’s views on interpreting the statutory construct of “confirmatory evidence,” a number of drug approvals over the past few years give us a great deal of insight into FDA’s current thinking and how FDA is applying this standard.

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FDA Documentation Labelling 61

DiversifyRx

OCTOBER 27, 2023

Segregation and Storage: Storing hazardous drugs separately from other medications, coupled with proper labeling and restricted access, prevents cross-contamination and ensures that only trained personnel have access to these substances. Proper documentation helps demonstrate adherence to safety measures and regulatory standards.

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Compounding Compounding Pharmacies Labelling Independent Pharmacies 52

The FDA Law Blog

OCTOBER 2, 2023

In 1997, the Food and Drug Administration Modernization Act (FDAMA) amended the definition to make clear that substantial evidence could also be demonstrated by “one adequate and well-controlled clinical investigation and confirmatory evidence.” However, the Act does not define what may constitute such confirmatory evidence.

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FDA Documentation Labelling Medical Records 64

The FDA Law Blog

MAY 19, 2023

Serial testing was defined as testing symptomatic individuals twice over three days with at least 48 hours between tests, which is in accordance with study findings from the National Institute of Health referenced here and current EUA labeling for serial testing. Customer Support Help line).

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Labelling FDA Documentation 40

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.

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Documentation Dosage Packaging Communication 52

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.

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Documentation Dosage Packaging Communication 52

ISPE

MAY 11, 2023

Also, determining whether an intrusion occurred and documenting that intrusion adds to the challenges of performing aseptic technique properly (and perhaps adds to the subjectivity of the current control strategies). Currently, no definitive method for ML software validation has been established by either regulators or industry.

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Documentation Labelling FDA 52

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

FEBRUARY 27, 2023

The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others. Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications.

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Controlled Substances FDA Documentation Communication 59

The Happy PharmD

OCTOBER 26, 2022

These documents focused on why the sentinel event occurred. Both the label and the product had to match the order before the product. No, but something was definitely wrong when I was checking the IV solutions.”. We found nothing wrong with the IV solutions or their labeling. Blaming Employees For Sentinel Events.

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Hospitals Labelling Medical Records Documentation 52

Viseven

NOVEMBER 17, 2022

Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug. They provide information about the following: Off-label usage Publications Safety information Independent medical education. What do medical affairs teams do? .

Communication 52

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

ISPE

MARCH 15, 2023

query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Table 2: Organization and labeling examples for environmental sustainability issues. 21 , 22 In this context, the term recycle has a few definitions. Accessed 3 December 2022.

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Packaging Labelling Health Compliance Process Improvement 52

ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Given the proliferation and confusion of various digital health terms, this article includes a compiled glossary of core DHT terms and definitions (see Table 1). Table 1: Terms and definitions for DHTs. Description. Artificial intelligence (AI)/machine. learning (ML).

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

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 ). For foods that do not have established definitions and standards of identity (i.e., The description or name of the food (i.e.,

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Labelling FDA Documentation Packaging 52

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

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Documentation Dosage FDA Communication 98

The FDA Law Blog

JANUARY 2, 2025

The proposed revised rule constituted a radical change from the original definition of healthy, which focused on the presence of individual (beneficial) nutrients. Under the proposed rule, any raw whole fruits and vegetables could be labeled healthy no matter the level of added sugars, sodium, or saturated fat.

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FDA Labelling Documentation 52

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. Ozempic is included, although the document notes that it requires prior authorization. What does that mean? It all depends on the provider and plan.

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Insurance Documentation Insurance Coverage Labelling 52

The FDA Law Blog

FEBRUARY 13, 2025

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

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FDA Documentation Labelling Method Validation 71

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. Provided that a brief device description, clear intended use, and list or picture of all labeling claims are made, FDA aims to review the information and provide a response generally within 7 days.

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FDA Documentation Labelling 69

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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Documentation FDA Labelling Communication 95

The Thyroid Pharmacist

NOVEMBER 8, 2024

Fermented foods are also great, and are definitely one of my 12 favorite beneficial healing foods for the gut. As such, I re-analyzed the data for the “presence” of parasite DNA labels, and the incidence was substantially higher… 274 total parasites were detected! (See my article on probiotics for more information on this.)

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Immunization Adverse Reactions Vaccines Hospitals 72