pharmaphorum

SEPTEMBER 29, 2022

Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. If so, developers must develop and execute on a regulatory strategy. This approach is known as exercising enforcement discretion. not a medical device, ii. 360c(g)).

Documentation 104

Documentation 104

ALiEM - Pharm Pearls

MARCH 8, 2023

Does this come at the expense of your documentation? It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. It definitely comes at the expense of my documentation but I haven’t found a way to improve that yet. My review is post-shift.

Documentation 147

Documentation Hospitals 147

European Pharmaceutical Review

JULY 5, 2023

Specifically, the document covers the development process of glass containers for pharmaceutical products, glass container sampling as well as definition of lots. In February 2023, the PDA released its Technical Report 90: Contamination Control Strategy Development in Pharmaceutical Manufacturing.

Pharmaceutical Manufacturing 96

Pharmaceutical Manufacturing Packaging Documentation Pharmaceutical Companies 96

European Pharmaceutical Review

NOVEMBER 14, 2023

In the document, it was reasoned that global shortage of these vials threatened the delivery of COVID-19 vaccines and availability of existing parenteral products.

Packaging 105

Packaging Vaccines Documentation 105

FDA Law Blog: Biosimilars

MAY 6, 2024

FDA interprets the “software” definition to include software that is firmware or programmable logic in addition to software in a medical device (SiMD) or software as a medical device (SaMD). For medical devices that meet the definition of a cyber device, manufacturers are required to submit specific information in premarket submissions.

Documentation 105

Documentation 105

pharmaphorum

OCTOBER 4, 2022

The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA regulates software that meets the definition of a medical device in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Criteria for regulation.

Documentation 105

Documentation Labelling Communication 105

pharmaphorum

JANUARY 28, 2022

It all just comes down to definitions. Much ink has been spilled about the fact that “digital health” as a category has no standardised definition. And if it’s hard to definitively separate companies into “digital health” and “not digital health”, it’s even harder to subdivide those companies into categories.

Documentation 141

Documentation 141

pharmaphorum

OCTOBER 11, 2022

In addition, RCTs don’t have to rely on two different data sources, which may have different operational definitions, assessment methods, and measurement timing. Documentation of detailed descriptions of the ECA population is critical, including the mechanisms and conditions that led to the patients being recorded in the data source.

Documentation 98

Documentation Medical Records Dosage Drug Development 98

European Pharmaceutical Review

SEPTEMBER 13, 2023

This will allow these firms to complete administrative procedures across the Single Market without needing to re-submit documents. Simplify administrative procedures and reporting requirements for SMEs by launching the Once-Only Technical System (part of the Single Digital Gateway ) by the end of 2023.

Communication 96

Communication Documentation 96

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Both ISO 13485 and ISO 9000 contain terms and definitions that are referenced within Part 820. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement. FDA further retained some definitions in the QSMR. Certain definitions are also removed from § 820.3,

Labelling 59

Labelling Packaging Documentation 59

FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

While a DEA registration is not required to sell these products, by definition, any person selling these products is a “regulated person” and all sales of these products are considered “regulated transactions.” 21 U.S.C. § 21 U.S.C. §§ 802(38), (39)(B). 1310.06.

Controlled Substances 116

Controlled Substances Documentation 116

Pharma in Brief

MAY 29, 2023

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection ( CSP Guidance ). Links: Notice: Publication of the Guidance Document: Certificates of Supplementary Protection – Canada.ca The CSP fee as of April 1, 2023 is $10,152 (increased from $9,952).

Documentation 59

Documentation 59

pharmaphorum

JUNE 10, 2022

In fact, the FDA’s definition of a medical device specifically excludes drugs. “A Because the device field is so vast, complicated, and rapidly changing, the FDA has issued and continues to issue a lot of guidance documents to provide regulatory clarity. FDA’s digital health regulation can be hard to parse, even for experts.

Documentation 133

Documentation 133

FDA Law Blog: Biosimilars

MARCH 7, 2024

Other Oversight Groups Both documents described the role of other oversight groups, in addition to DMCs, that may be involved in a clinical trial in similar, sometimes overlapping, roles such as IRBs, trial steering committees, and site monitors. Increased Connections Between a DMC and FDA?

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

pharmaphorum

SEPTEMBER 30, 2021

It also focuses on the development and validation of definitions for study design elements, and maintaining the provenance and quality of data during “accrual, curation, and transformation into the final study-specific dataset. The post FDA posts guidance on mining real-world data from health records appeared first on.

Documentation 95

Documentation 95

GMPSOP

MARCH 25, 2024

Additional documents included each month. Category 1 Standard hardware components Standard hardware components should be documented, including manufacturer or supplier details and version numbers. Any hardware configuration should be defined in the design documentation and verified in the installation qualification stage.

Documentation 59

Documentation Packaging Communication Pharmaceutical Companies 59

Syner-G

AUGUST 17, 2023

By Maria WIk, MS VP, CMC Development The ICH Q10 definition for a Control Strategy is: “ A planned set of controls, derived from current product and process understanding, that assures process performance and product quality.” The process control strategy doesn’t remain confined to mere documentation, it reaches regulatory recognition.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

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.

Documentation 59

Documentation Packaging Clinical Pharmacology Drug Development 59

European Pharmaceutical Review

SEPTEMBER 26, 2023

However, due to configuration differences between databases (such as code list definitions), cases may not always be an exact replica of the original case. Any discrepancies should be documented using a Known Difference document and the solutions or acceptance of the discrepancy are then agreed upon.

Documentation 105

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 105

RX Note

MAY 21, 2023

NOTE: Every HTML document starts with a document type declaration: This declaration sets the document type and ensures proper rendering of the page. Lists Build lists of items using (unordered list), (ordered list), (definition list) elements. HTML Elements HTML elements are the building blocks of web pages.

Documentation 52

Documentation 52

pharmaphorum

FEBRUARY 9, 2021

It makes for an agreement which is neither a legal document nor a policy one. These metrics are largely operational; pragmatic yes, comprehensive, definitely not. A deal that definitely delivers for government . Overall sales and sales by scheme (which includes the statutory scheme). Growth gross of payment.

Documentation 87

Documentation 87

GMPSOP

JUNE 28, 2024

Additional documents included each month. Additional documents included each month. Material complaint: raised to document any issues regarding non-conforming, superseded, or obsolete raw materials/components, packaging, or imported finished goods v. Additional documents included each month. Checkout sample preview s.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

FDA Law Blog: Biosimilars

MAY 15, 2023

A major component of AAFCO is its work on ingredient definitions, specifying what ingredients may be use in animal feed under what conditions. AAFCO’s ingredient definitions are not federal regulations and do not have the force or effect of federal law. This document also describes an appeal procedure.

Labelling 45

Labelling Documentation 45

UNC Eshelman School of Pharmacy

JUNE 28, 2017

Such study designs allow the researcher to say intervention x caused result y definitively. This project will document the critical factors for its successful implementation. Testing cause and effect can often lead researchers to control the environment of the study to the point that it doesn’t reflect reality in practice.

Documentation 52

Documentation 52

European Pharmaceutical Review

JULY 4, 2024

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. 2 In addition, the nature of botanical products adds another layer of complexity in terms of obtaining FDA approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

Pulses

APRIL 4, 2023

However, students may benefit more from being explicitly taught the definition and process of CT before encountering it as embedded content. It is likely that most pharmacy school curricula have CT embedded in courses that involve group work and problem-based learning scenarios.

Doctor of Pharmacy 98

Doctor of Pharmacy Documentation 98

Express Pharma

AUGUST 2, 2023

The summit deliberations are outcome driven, and based on the deliberations, we are drafting the ‘Digital Transformation Roadmap’ document and making it available to the healthcare providers giving them guidance on how to move ahead with their tech adoption journey. How does the Summit address this reality?

Hospitals 98

Hospitals Nursing Homes Documentation 98

European Pharmaceutical Review

NOVEMBER 28, 2024

Regulations rife with inconsistency The EU AI Act’s lack of precise definitions mirrors issues seen in the early days of the GDPR.

Documentation 105

Documentation Compounding 105

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.

Biosimilars 98

Biosimilars Labelling Documentation 98

GMPSOP

AUGUST 23, 2022

Assessing the impact of changes to a process/system The use of quality risk management and the methodology to be used should be documented in the relevant validation plan or change management procedure. Additional documents included each month. Additional documents included each month. Assessing validation failures/deviations 4.

Documentation 52

Documentation Communication Pharmaceutical Manufacturing Labelling 52

Syner-G

MAY 4, 2022

As highlighted in these guidance documents, the FDA offers five programs: fast track designation, breakthrough therapy designation, regenerative medicine advanced therapy (RMAT) designation, accelerated approval and priority review designation. Image courtesy of qimono at pixabay.com.

Documentation 52

Documentation Drug Development Communication 52

pharmaphorum

JANUARY 27, 2023

What I’ve seen with patient centricity over the last few years is really a broadening of the definition,” Dr Mullen explained. Clinical trials design and patient input The definition of patient centricity, in fact, and its benefits are now – finally – being defined by patients themselves. “We

Vaccines 111

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 111

FDA Law Blog: Biosimilars

FEBRUARY 6, 2024

In fairness, we’d note that FDA reports that inspections are on the rise—but definitely not back to pre-pandemic levels. The Subcommittee majority has held prior hearings and written letters about these problems, as the issue has vexed FDA in recent years.

Documentation 52

Documentation 52

FADIC

AUGUST 12, 2023

Simple random sampling: Definition, examples, and how to do it The post Best Keyboard Shortcuts appeared first on FADIC. Keyword Focus: Best Keyboard Shortcuts, Improve Productivity and Computer Experience. Check Now the FADIC Book store and Buy books in different specialities. Check Now about Coronavirus Resource Information Center.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

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. Remarkably, manufacturers may not dispute a CMS notification. 1396r-8(k)(3).

Vaccines 59

Vaccines Inpatient Packaging Documentation 59

GMPSOP

MARCH 17, 2023

By definition, corrective actions are required to eliminate the causes of an existing nonconformity, defect, or other undesirable situation. Additional documents included each month. Additional documents included each month. Corrective actions are taken to fix a defect on hand. All written and updated by GMP experts.

Documentation 52

Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

FADIC

OCTOBER 20, 2023

■ All follow-up evaluations and interactions with the patient and his or her other healthcare professional should be included in MTM documentation. Simple random sampling: Definition, examples, and how to do it The post Medication Therapy Management in geriatric appeared first on FADIC. 2014;11(4):329-337. doi:10.11909/j.issn.1671-5411.2014.04.008

Health and Personal Care Stores 52

Health and Personal Care Stores Documentation Medication Therapy Management (MTM) Medical Records 52