pharmaphorum

SEPTEMBER 28, 2022

The nine-company pilot launched in 2017 and is designed to explore a new approach to regulating digital health, based on certifying companies and their internal processes rather than individual devices and apps. The Pre-Cert pilot report. O’Leary said.

Documentation 135

Documentation 135

Putting Patients First Blog

APRIL 14, 2025

The proposal to eliminate the automatic 60-day extension for providing income verification documentation could result in disenrollment of eligible individuals unable to promptly produce required documentation.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Documentation Hospitals Communication 52

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

Controlled Substances 139

Controlled Substances Documentation Dosage Prescription Filling 139

FDA Law Blog: Biosimilars

MAY 13, 2024

It was Congress that intervened in 2022, to mandate FDA to issue or revise its 2017 guidance on considerations for the use of RWD and RWE to support regulatory decision-making for devices to clarify its regulatory expectations. This guidance, when finalized, will replace the original version of this document finalized in 2017.

Medical Records 111

Medical Records Documentation 111

pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

Eye on FDA

AUGUST 10, 2023

The number of press releases issued by FDA during the first six months of the year declined to 101 from the 125 issued by June 30 of last year, the lowest number at mid-year since 2017. In 2018, FDA issued a much larger number of releases – trend that continued through 2022, all years with much larger numbers than were seen in 2017.

Communication 80

Communication Documentation 80

Pharma in Brief

JANUARY 20, 2021

Also on January 18, 2021, the FC issued a new Practice Direction outlining its Document Retention Schedule, including new plans for the destruction of certain archived documents. Gowning for in-person hearings remain subject to the Notice of February 6, 2017. Service of Documents. Document Retention Schedule.

Documentation 52

Documentation 52

pharmaphorum

OCTOBER 29, 2020

By 2017, NICE added the Preliminary Independent Model Advice (PRIMA) service. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE.

Documentation 101

Documentation Drug Development 101

Pharma in Brief

OCTOBER 29, 2020

These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession: Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015) ; Trial Management Guidelines (April 2017) ; Intellectual Property (experimental testing) (May 12, 2016) ; and.

Documentation 52

Documentation 52

Express Pharma

AUGUST 2, 2023

The Government has already made its intent clear in the National Health Policy 2017 about creating the Digital Health Ecosystem and has moved to institutionalising technology adoption in healthcare through ABDM. What are the policy initiatives we need for India to reap the insights of digital health solutions available today?

Hospitals 98

Hospitals Nursing Homes Documentation 98

pharmaphorum

APRIL 6, 2021

A Life on Wheels started out as Ross’ hobby back in 2017 and has been growing steadily ever since. It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says. A resonating hobby.

Documentation 132

Documentation 132

FDA Law Blog: Biosimilars

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

Documentation 52

Documentation 52

European Pharmaceutical Review

JUNE 12, 2024

European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2017; 55(7):1998-2008. Clin Microbiol Infect. 2021; 27 (2): S1-S21. McDonald CL, Gerding DN, Johnson S, et al. Lancet Gastroenterol Hepatol. 2022; 7(12):1083-1091.

Documentation 111

Documentation Labelling Hospitals 111

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Documentation 105

Documentation Drug Development Communication 105

Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% All top 20 biopharmaceutical companies recorded positive compound annual growth rates (CAGRs) in revenue during 2017–21, with BioNTech (319%) and Moderna (208%) leading thanks to their Covid-19 vaccine franchises.

Vaccines 108

Vaccines Drug Pricing Biosimilars Documentation 108

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 Certificate of Supplementary Protection Regulations , SOR/2017-165

Documentation 59

Documentation 59

pharmaphorum

DECEMBER 28, 2022

This review will include key documents such as minutes of management review meetings and quality metrics which will enable them to quickly assess the company’s approach to quality and compliance and the current level of control. She joined NSF in 2017.

Pharmaceutical Manufacturing 119

Pharmaceutical Manufacturing Documentation Pharmaceutical Companies Pharmaceutical Companies 119

RX Note

NOVEMBER 19, 2023

On the other hand, Medical Nutrition Therapy Guidelines for Critically Ill Adults is published by Malaysian Dietitians Association in 2017. This handbook complements the limited info available in Paediatric Protocols for Malaysian Hospitals. There is also a chapter of nutritional support in Critical Care Pharmacy Handbook, 2020.

Hospitals 52

Hospitals Documentation Compounding 52

Pharma in Brief

DECEMBER 3, 2023

Full actions (2017–present). The most significant amendments came into force in September 2017, when the Regulations were completely overhauled (discussed here ). The first section 6 actions under the amended Regulations were started in December 2017 (discussed here ). Where we are now Staying power. Fast-paced.

Biosimilars 52

Biosimilars Dosage Documentation 52

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

Safe Biologics

FEBRUARY 1, 2024

Over the years, the WHO has attempted to evaluate the BQ: a provisional implementation of the programme was suggested in 2016, and in 2017 a pilot BQ project was discussed. Other supporting agencies await the WHO implementing a global system. In 2018, the project was put on hold for data gathering.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

pharmaphorum

OCTOBER 20, 2020

Documenting the change in pharma’s engagement of HCPs is one thing – predicting where channel mix goes in the future, the most important question, is quite another. The UK is also unique compared to other countries as remote detailing has risen and continues at close to peak levels. In the US, the trend had already started pre-COVID-19.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist.

Communication 64

Communication Documentation Labelling Pharmaceutical Companies 64

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. They show that England was sixth and Scotland tenth out of 13 countries when ranked according to the percentage of new medicines made available to patients.

Documentation 98

Documentation 98

Pharmacy Joe

NOVEMBER 22, 2023

This is not the first time the US has dealt with a shortage of this product as back in 2017 there was a nationwide shortage due to manufacturing delays. The current guidance in the Pfizer document states: Limited inventory released direct and to wholesalers/distributors in part or full when available.

Hospitals 52

Hospitals Inpatient Documentation 52

Pharmacy Joe

NOVEMBER 22, 2023

This is not the first time the US has dealt with a shortage of this product as back in 2017 there was a nationwide shortage due to manufacturing delays. The current guidance in the Pfizer document states: Limited inventory released direct and to wholesalers/distributors in part or full when available.

Hospitals 52

Hospitals Inpatient Documentation 52

Pharmaceutical Technology

MARCH 30, 2023

The PD-1 inhibitor received an accelerated approval for this indication back in May 2017. There, the FDA suggested that the drugs undergo randomised controlled trials, which the document describes as the preferred approach, rather than single-arm trials.

Chemotherapy 52

Chemotherapy Packaging Documentation 52

pharmaphorum

FEBRUARY 26, 2021

From 2015 to 2017, when the cost of the drug was falling, the three suppliers exchanged information about prices, the volumes they were supplying, and Alissa’s plans to enter the market,” said the CMA.

Documentation 52

Documentation 52

RX Note

NOVEMBER 13, 2023

Registered companies Governed under Companies Act 1965 (companies registered before 2017) or Companies Act 2016 (companies registered since 1 January 2017). Records and documentations should be kept and updated systematically as stipulated by the law. Make your application through MyPharma-C website.

Community Pharmacies 52

Community Pharmacies Health and Personal Care Stores Documentation Independent Pharmacies 52

pharmaphorum

OCTOBER 11, 2022

It is subject to a two-year clinical stopping rule, as for now it remains uncertain the benefits of the regimen extend beyond that timepoint and whether continuing to give it will remain cost-effective, according to the SMC’s assessment document.

Chemotherapy 52

Chemotherapy Documentation 52

pharmaphorum

DECEMBER 6, 2022

He calls out a particular opportunity in the United Kingdom, where COVID-19 and other factors have reduced patient access to clinical trials by 44% since 2017. When I first started working in clinical trials, people were just moving from paper documentation to EDCs,” Peleg says.

Data Entry 98

Data Entry Communication Hospitals Documentation 98

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

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. This increases direct patient care practice abilities, creates awareness among intensive care team, and prevents medication errors. ■ Frequency of dose and administration time.

Health and Personal Care Stores 52

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

FDA Law Blog: Biosimilars

SEPTEMBER 27, 2023

Tobolowsky — Much has changed since the long-gone days of 2017. While the Nats being replaced by the Orioles as the dominant home team did not get a mention in the new Draft Guidance, there were plenty of other interesting changes made to the old 2017 draft guidance. By James E. Valentine & Mark A. Now, we know better.

Packaging 64

Packaging Drug Development Documentation 64

Syner-G

APRIL 27, 2023

In addition, the OPEN Act, introduced in 2017, can extend the exclusivity period of a previously approved drug by another six months. Each component of the application must be addressed completely and provide detailed information.

Drug Development 52

Drug Development Documentation 52

Pharmacy Joe

NOVEMBER 14, 2021

In 2017 the authors developed and implemented a procedure requiring an opioid status verification by a pharmacist for all fentanyl patch orders. Documentation within the medical record. This 3-step procedure includes: 1. Determination of indication 2. Review of prior opioid use 3.

Hospitals 40

Hospitals Medical Records Inpatient Documentation 40

RX Note

AUGUST 25, 2024

Fenugreek has been documented to have uterine stimulant effects and has been used in traditional medicine to induce childbirth. External Links Blackmores Institute 'Unsafe' Nutraceuticals Products on the Internet: The Need for Stricter Regulation in Malaysia, 2017 What risks do herbal products pose to the Australian community?,

Diabetes 52

Diabetes Community Pharmacies Dosage Documentation 52