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A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device.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

Documentation 135

Documentation 135

ALiEM - Pharm Pearls

MARCH 29, 2023

Children 29 days or older with fever from a documented viral source can be managed according to their clinical presentation and can go outside the algorithm. This requires a documented positive viral swab and not just a presentation consistent with a viral syndrome. 2019 Mar; 2(3). Biondi EA, Lee B, Ralston SL, et al.

Hospitals 360

Hospitals Documentation Inpatient Immunity 360

NY Times

JULY 30, 2021

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

Documentation 64

Documentation Vaccines Immunity Immunization 64

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

RX Note

DECEMBER 25, 2024

Demystifying Drug Dosing in Renal Dysfunction, 2019 Demystifying Drug Dosing in Renal Dysfunction serves as a quick reference for commonly used medication dosing given varying degrees of renal dysfunction and/or use of renal replacement modalities.

Dosage 40

Dosage Documentation Hospitals 40

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 111

Pharma Pathway

JANUARY 6, 2023

Passed out year: 2019 -2020. Kindly Carry the below Documents with you: . Walk-In Interviews for Freshers On 7th Jan’ 2023 @ Granules India Limited (Gagillapur-Hyderabad). Qualification: Intermediate (M.P.C/ Age: 18 -20 years. Percentage: passed Candidates with Consistent academic record of min 55% in 10th & Intermediate.

Pharmaceutical Manufacturing 81

Pharmaceutical Manufacturing Documentation 81

Pharma Pathway

FEBRUARY 14, 2023

Working: Corporate Office’ Secunderabad Department: Maintenance (Formulation) -Assistant Manager Qualification: Diploma / B.Tech Experience: 05-08 years (Pass Out: 2019 to 2022) Skills: OSD/ OLD-Manufacturing (Formulation), maintenance management, HVAC, Water System, EHS Knowledge, Air Compressor, Documentation, Vacuum pumps.

Documentation 64

Documentation Communication 64

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

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

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 Immunity 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 Drug Development 101

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

Documentation 52

Documentation Packaging Pharmaceutical Manufacturing 52

FDA Law Blog: Biosimilars

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.

Documentation 115

Documentation 115

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

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

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 Immunity Immunization 98

FDA Law Blog: Biosimilars

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 64

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 Pharmaceutical Companies Pharmaceutical Companies 98

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.

Documentation 95

Documentation 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

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

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

Drug Channels

JULY 21, 2020

Last week, I documented that nearly half of U.S. We estimate that specialty pharmacy dispensing accounted for nearly one-third of PBMs’ total gross profits in 2019. pharmacies now participate in the 340B Drug Pricing Program. Below, we update our exclusive analysis of the biggest specialty pharmacies within 340B.

Specialty Pharmacies 52

Specialty Pharmacies Drug Pricing Documentation Hospitals 52

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

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

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

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.

Pharmaceutical Manufacturing 59

Pharmaceutical Manufacturing Packaging Documentation Communication 59

FDA Law Blog: Biosimilars

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.

Drug Development 64

Drug Development 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 Drug Pricing Biosimilars Documentation 108

GMPSOP

JUNE 28, 2024

Additional documents included each month. In the five years between 2019 and 2023, the FDA issued the following warning letters, closely related to ineffective deviation investigation. In 2019 and 2020, warning letters were issued for “Adulterated Food and Supplements” at 36% and 33%, respectively. Checkout sample preview s.

Documentation 59

Documentation Packaging Labelling Pharmaceutical Manufacturing 59

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.

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88