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

Pharma in Brief

JANUARY 12, 2022

Removal of documents improperly filed: A document may be ordered removed from the judicial record on the grounds that it is scandalous, frivolous, vexatious or clearly unfounded. The definition of “Christmas recess” has been replaced with the more inclusive “seasonal recess”.

Documentation 52

Documentation 52

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

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 71

Pharmaceutical Manufacturing Packaging Documentation Pharmaceutical Companies 71

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

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

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

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

ALiEM - Pharm Pearls

MARCH 29, 2023

Well-appearing febrile infants The AAP acknowledges that clinician experience is likely the best determinate of what is “well-appearing”, further admitting that there is no measure or definition of either “experience” or “well-appearing” Febrile Rectal temperatures of 38.0C What should be done if the viral panel is positive ?

Hospitals 360

Hospitals Documentation Inpatient Immunity 360

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

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 93

Documentation 93

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

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

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

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

Pharma in Brief

JANUARY 10, 2024

At the same time, the definition of a “small entity” under the Patent Rules was broadened as of January 1, 2024. The employee count cut-off in all small entity definitions has increased from 50 to fewer than 100. Many fees will increase by 25% or more, though some “low materiality fees” will remain capped at $150.

Drug Pricing 52

Drug Pricing Documentation Biosimilars Vaccines 52

FADIC

OCTOBER 20, 2023

Project management services for healthcare The trust also uses the knowledge and experience of our in-house managers in developing new standardised documents and processes for optimum project delivery under the NEC form of contract used by the trust. Check Now the FADIC Book store and Buy books in different specialities.

Hospitals 52

Hospitals Documentation 52

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

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

RX Note

DECEMBER 17, 2023

SODA - Sale of Drugs Act 1952 CDCR - Control of Drugs and Cosmetics Regulations 1984 DCA - Drug Control Authority Key Definitions "Drug" includes any substance, product or article intended to be used or capable, or purported or claimed to be capable, of being used on humans or any animal, whether internally or externally, for a medicinal purpose.

Documentation 40

Documentation Labelling 40

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 91

Documentation Data Entry Pharmaceutical Companies Pharmaceutical Companies 91

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

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 80

Biosimilars Labelling Documentation 80

STAT

FEBRUARY 9, 2024

Surgeon General Luther Terry’s landmark Report, “ Smoking and Health ,” which definitively documented the causal link between smoking, disease, and death. Over the decades, cigarettes have been responsible for death and disease in millions of Americans. January marked the 60 th  anniversary of U.S.

Documentation 362

Documentation 362

Syner-G

APRIL 27, 2023

Each component of the application must be addressed completely and provide detailed information.

Drug Development 52

Drug Development Documentation 52

Board Vitals - Pharmacist

APRIL 22, 2022

This method is truly a type of self-directed learning in which you document a clinical question, the sources consulted, and the application to your practice. . Participation in a committee where the subject is within the definition of CME. . Other Ways to Earn CME .

Documentation 52

Documentation 52

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

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

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

RX Note

JULY 30, 2023

However, this definition does not consider the following scenarios, all of which can also cause ADRs. Also, it is important to Document the ADR in the patient's medical record. Is it safe? What other medicines can be used instead? Whether a dose reduction is feasible or practical. The ability to successfully treat the side effect.

Adverse Reactions 52

Adverse Reactions Patient Counseling Medical Records Documentation 52

GMPSOP

NOVEMBER 6, 2022

These standards can only be used if they are standardized against primary standards using definitive methods that are published in pharmacopoeias, and national and international standards. Additional documents included each month. Additional documents included each month. All written and updated by GMP experts.

Labelling 52

Labelling Documentation Packaging Communication 52

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

ID Stewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Not too say it is as dramatic as the latter part of that statement, but it is a definite narrowing.

Communication 52

Communication Documentation Vaccines 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 110

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 110

Pharma in Brief

APRIL 20, 2021

These provisions relate to service and filing requirements for the notice of motion and motion record; the form of written submissions required; documents to be included in the record; and requests for an oral hearing.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

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.”

Packaging 59

Packaging Documentation Labelling Communication 59

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