European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. Implementation of the ICH M10 document The EU date of coming into effect of the core ICH M10 document and the corresponding Q&As was 21 January 2023.

Method Validation 98

Method Validation Documentation FDA 98

pharmaphorum

SEPTEMBER 28, 2022

A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device. “I O’Leary said.

FDA 135

FDA Documentation 135

pharmaphorum

FEBRUARY 4, 2021

The experts were also involved in the “Digital Therapeutics for Italy – #DTxITA”, established in 2019 to encourage the implementation of DTx in Italian institutions and healthcare systems. Healthware Group, an international integrated consulting group also based in Italy, contributed to the white paper. “At

Documentation 139

Documentation Communication 139

ISPE

OCTOBER 28, 2022

was published in 2019, most of the attention was focused on the incorporation of quality risk management (QRM) into the integrated commissioning and qualification (C&Q) approach. Appropriate ECM and document management ensures that proposed changes are identified, assessed for impact, implemented, and verified. Chip Bennett, PMP.

Documentation 98

Documentation 98

European Pharmaceutical Review

DECEMBER 21, 2022

1 The European Directorate for the Quality of Medicines & Healthcare (EDQM) also accepted LBP as a new category of medicinal products for the European market in 2019. Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation.

Documentation 111

Documentation FDA 111

Hospital Pharmacy Europe

FEBRUARY 24, 2023

However, in its consultation document, while accepting that the drug is likely to reduce pain at 2 hours post-dose more than placebo, NICE added that the evidence submitted by the manufacturer, for patients who have not responded to two triptans, is uncertain and hence requires more evidence. .’

Documentation 96

Documentation Hospitals 96

pharmaphorum

AUGUST 18, 2022

Endo’s slide into bankruptcy follows in the footsteps of Purdue Pharma – which filed in 2019 but is still negotiating opioid settlement and corporate restructuring terms – as well as Mallinckrodt which emerged from chapter 11 after agreeing a $1.6 billion settlement earlier this year. .” Pharmacy chains ordered to pay $650m.

Documentation 108

Documentation 108

Pharmaceutical Technology

APRIL 24, 2023

The draft guidance is open for feedback from consultees after which the document and its recommendations will be used to establish the organization’s guidance on the use of this combination regimen for patients in the UK’s National Health Services.

Documentation 98

Documentation 98

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. There is enough evidence accumulating to predict that the commercial model of the 2020s will not be a return to 2019, with COVID-19 a “blip”.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

European Pharmaceutical Review

NOVEMBER 18, 2022

The document showed that in 2021, approximately 16 billion vaccine doses, worth $141 billion, were supplied across 47 vaccines and 94 manufacturers. This is almost three times the 2019 market volume (5.8 billion), nearly three-and-a-half times the 2019 market value ($38 billion).

Vaccines 98

Vaccines Immunization Documentation 98

pharmaphorum

OCTOBER 29, 2020

Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20. 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 NICE-CADTH service was launched in 2019. What is the impact?

Documentation 101

Documentation 101

The FDA Law Blog

JANUARY 15, 2024

FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. At an October 2019 Meeting , FDA explained the application process and provided assurances that decisions would be made on each specific product in a submission—not the submission in its entirety.

FDA 115

FDA Documentation 115

pharmaphorum

FEBRUARY 10, 2021

While the foundations remain the same, the updated code, which comes into force on 1 July, is structured differently to the 2019 version. Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. Change management.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

Pharmaceutical Technology

MARCH 30, 2023

One route to more engaged patients is clear, accessible information – but clinical trial documentation is often highly technical and full of jargon. Plain language summaries simplify clinical trial documentation, using language that any non-expert could understand. So why are so many clinical trials falling short of enrolment targets?

Documentation 99

Documentation Communication 99

pharmaphorum

SEPTEMBER 6, 2021

Now, it reached an agreement with creditors that would increase that settlement payment to $1.725 billion, which will be paid into a trust that will be used to support people whose lives have been affected by opioid use, according to documents submitted to the Securities & Exchange Commission (SEC).

Documentation 98

Documentation Immunization 98

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation 98

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 98

The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

Documentation 64

Documentation FDA 64

pharmaphorum

SEPTEMBER 30, 2021

In some respects the agency is playing catch-up in this area, as it has already approved the first new indication for a drug based on real-world evidence (RWE) alone – a filing to expand the breast cancer indication for Pfizer’s Ibrance (palbociclib) to include men in 2019.

FDA 95

FDA Documentation Insurance 95

pharmaphorum

MARCH 5, 2021

“The opening of a formal investigation is a procedural step, which simply means that the Commission will be able to dedicate more ample resources to examining the information and documents collected during the inspection that commenced in October 2019, and the subsequent requests for information. “It

Documentation 98

Documentation Communication Hospitals 98

pharmaphorum

JANUARY 20, 2023

Leela Barham argues that the latest operational guidance for the NHS in England continues to illustrate a disconnect between the messages in big-ticket policy documents from the central government and the messages from the NHS in England on medicines. billion, according to the ABPI. The post Crossed wires?

Documentation 105

Documentation Hospitals 105

pharmaphorum

NOVEMBER 17, 2020

An international key opinion former, Richard is the founding co-editor of the Journal of Research Involvement and Engagement, chairs BBMRI-ERIC’s Stakeholder Forum, and chaired the NCRI Consumer Forum 2012-2019.

Documentation 116

Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals 116

pharmaphorum

APRIL 13, 2022

NICE’s final appraisal document for Vumerity has been welcomed by patient organisation the MS Trust, which said that Vumerity is as effective as Tecfidera but has fewer gastrointestinal side effects like nausea, vomiting, diarrhoea and upper & lower abdominal pain. billion from the US market.

Documentation 64

Documentation 64

pharmaphorum

DECEMBER 8, 2022

Instead, there are hints from other documents that are published by the government about just what the LSC is there to do. The 2018 publication of the 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS) made mention of the LSC. UK fiscal incentive landscape (May 2019). Terms of reference.

Documentation 105

Documentation 105

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. percent for large enterprises, which is lower than its 2019 level. Boost investments available for SMEs , for example, ensuring that part of the proposed €7.5 This is compared to 1.8

Communication 96

Communication Documentation 96

European Pharmaceutical Review

DECEMBER 23, 2022

To enable this, the design documentation, whitepaper and testing results have been made available open source to all, 6 with the hope that we will see this technology become the standard for buffer preparation as we look to create further efficiencies in the future. . cited 2022Nov]. Available from: [link]. 2022 [cited 2022Nov].

Documentation 98

Documentation 98

European Pharmaceutical Review

APRIL 10, 2025

billion Global concerns surrounding PFAS, or per- and polyfluoroalkyl substances, are due to their well-documented effects on human health and the environment. Annual health-related costs related to PFAS across Europe are estimated at up to 4.6 www.eea.europa.eu. Available from: [link] Goldenman G, Fernandes M, Holland M, et al.

Packaging 59

Packaging Documentation Communication 59

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.

FDA 105

FDA Documentation Communication 105

The FDA Law Blog

OCTOBER 2, 2023

The new guidance is one of three policy documents dedicated to explaining FDA’s interpretation of this statutory authority and their approach to exercising scientific judgment in evaluating drug effectiveness. We are heartened to see that this latest guidance reflects many of the advances we observed in practice since 2019.

FDA 64

FDA Documentation Labelling Medical Records 64

Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s report, Coronavirus Disease 2019 (Covid-19) Analyst Consensus Sales Analysis and Forecast, H1 2022 , Comirnaty is the leading prophylactic Covid-19 vaccine and recorded sales of $41.3bn in 2021. Bristol Myers Squibb (BMS) documented a 9.1%

Vaccines 108

Vaccines Documentation Compounding FDA 108

The Checkup by Singlecare

JUNE 28, 2024

Additionally, certain commercial insurance plans require a documented period of three to six months of enrollment in a lifestyle program before qualifying for the medication.” If additional documentation is needed, it can be submitted at this stage.” How much does Ozempic cost without insurance?

Insurance 96

Insurance Insurance Coverage Labelling Medical Records 96

Hospital Pharmacy Europe

SEPTEMBER 26, 2023

This was significantly more than the previous year, and follows a steady increase since 2019. According to the PSA’s review, in 2022/23 the GPhC had 77 FtP cases that had been open for at least 156 weeks; 103 that had been open for between 104 and 155 weeks; and 250 cases that had been open for between 52 and 103 weeks.

Documentation 105

Documentation Hospitals 105

The Checkup by Singlecare

MARCH 10, 2025

This process could require the healthcare provider to submit documentation that Januvia is necessary. In fact, a 2019 study from the U.S. Some might require prior authorization , which is the insurance providers way of ensuring the prescription is medically necessary. Is there a cheaper alternative to Januvia?

Insurance 52

Insurance Insurance Coverage Documentation 52

pharmaphorum

APRIL 27, 2021

Today (27 April), the ODAC is due to look at Tecentriq in combination with BMS/Celgene’s Abraxane (nab-paclitaxel) for people with advanced triple-negative breast cancer (TNBC) whose tumours express PD-L1, an indication which was provisionally approved by the FDA in 2019 on the strength of the Impassion130 study.

FDA 90

FDA Chemotherapy Documentation 90

pharmaphorum

JANUARY 28, 2022

But never mind, 2021 was a blockbuster even compared to 2020 or 2019, with many sources saying there was twice as much, or nearly twice as much money raised this past year compared with the year before. For comparison, when we last reported on sector liquidity in 2019, only 15% of digital health’s investment dollars had exited.”.

Documentation 141

Documentation 141

The FDA Law Blog

OCTOBER 11, 2022

Additional guidance on confirmatory evidence is sorely needed as the December 2019 draft guidance spends just two of its 18 pages telling us what FDA thinks of such a key piece of statutory language. However, we wonder whether recent and ongoing approval decisions are shaping FDA’s thinking, possibly pushing back issuance of a draft.

FDA 61

FDA Documentation Labelling 61

pharmaphorum

AUGUST 11, 2021

A final appraisal document from the health technology assessment (HTA) agency backs the use of Verzenio (abemaciclib) alongside fulvestrant for the treatment of women with hormone receptor-positive, HER2-negative breast cancer in England and Wales. . That route is however not available to people in Wales.

Chemotherapy 64

Chemotherapy Documentation Hospitals 64

pharmaphorum

FEBRUARY 9, 2021

In the final instalment of our series reviewing the t he 2019 Voluntary Scheme for Branded Medicines Pricing and Access (VPAS), Leela Barham takes stock of the whole scheme after digging more deeply into its three objectives. It makes for an agreement which is neither a legal document nor a policy one.

Documentation 87

Documentation 87