pharmaphorum

JANUARY 18, 2021

In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceutical companies in the world” based in New Jersey.

Documentation 79

Documentation Immunization Pharmaceutical Companies Pharmaceutical Companies 79

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A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device.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 132

FDA Documentation 132

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510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.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

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

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 101

Documentation FDA 101

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The draft guidance is open for feedback from consultees after which the document and its recommendations will be used to establish the organization’s guidance on the use of this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

Hospital Pharmacy Europe

AUGUST 17, 2023

11 Many documents and checklists detail every stage of the pathway in preparing CAR T. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. 12 The document aims to harmonise the implementation of hospital pharmacy CAR T services. Farm Hosp 2020;44(1):26–31.

Hospitals 98

Hospitals Documentation Chemotherapy Pharmaceutical Companies 98

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 62

Documentation 62

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 83

Vaccines Immunization Documentation 83

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 91

Documentation 91

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

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 85

Documentation FDA Pharmaceutical Companies Pharmaceutical Companies 85

ISPE

APRIL 19, 2023

For this reason, not repeating tests once they have been executed is a very valid strategy recommended since 2019 by the commissioning and qualification guides. This strategy, and which test is susceptible to carry it out or not, must be set out in a document and this activity corresponds to the PM.

Documentation 52

Documentation Communication 52

pharmaphorum

NOVEMBER 16, 2021

NICE notes in its final appraisal document (FAD) for the drug that many patients with this form of epilepsy may have to try a range of medicines, both alone and in combination, in order to control seizures. Cenobamate was originally developed by South Korean biotech SK Biopharmaceuticals, and was approved as Xcopri in the US in 2019.

Documentation 91

Documentation 91

STAT

NOVEMBER 18, 2022

The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. As of 2019, about 1.9 The treatment comes as a 14-day course of infusions that each last 30 to 60 minutes.

FDA 98

FDA Documentation Compounding Pharmaceutical Companies 98

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 97

Documentation Immunization 97

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 78

FDA Documentation Insurance 78

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 96

Documentation 96

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 107

Documentation Pharmaceutical Companies Pharmaceutical Companies 107

Pharmaceutical Technology

AUGUST 26, 2022

As per the Institute for Health Metrics and Evaluation, TB incidence has massively reduced globally in the last few decades, with a fall from 164 cases per 100,000 people in 1990 to 109 cases per 100,000 individuals in 2019. The mortality rate has also reduced from 33 to 15 deaths per 100,000 people from 1990 to 2019.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

pharmaphorum

OCTOBER 19, 2022

While there is no direct comparison between Tavlesse and these agents, the document says that an “indirect comparison” shows that Grifols’ drug works better than rituximab at increasing the number of platelets in the blood and is an acceptable use of NHS resources at the discounted price offered by the manufacturer.

Immunization 52

Immunization Documentation 52

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 deprescribing.org Blog

APRIL 14, 2021

Document, document, document. Pharmacists can partially address this issue by committing to thorough documentation practices at their own pharmacies. Pharmacists can partially address this issue by committing to thorough documentation practices at their own pharmacies. 2019 Jan 1;99(1):7-9. Am Fam Physician.

Community Pharmacies 52

Community Pharmacies Documentation Hospitals Communication 52

pharmaphorum

APRIL 16, 2021

NICE noted in its guidance document that “patient experts explained that the fortnightly infusions make it difficult for people to work, socialise and join in with family life.” Ultomiris is Alexion’s follow-up to its rare diseases blockbuster Soliris (eculizumab), which allows for an eight-week dosing schedule after a loading phase.

Documentation 52

Documentation 52

pharmaphorum

NOVEMBER 17, 2022

Briefing documents published ahead of the meeting suggest it still has concerns about the efficacy of Xphozah, particularly that the magnitude of its effect is less than with binder drugs like sevelamer. In severe cases it can cause bone and muscle problems as well as increase the risk of heart attacks and strokes.

FDA 52

FDA Documentation 52

Impact Pharmaceutical Services

MAY 4, 2022

In May of 2014 and February of 2019 , the FDA released final Guidance for Industry outlining the Agency’s policies and procedures regarding expedited development and review programs for new drugs and biologics intended to treat serious or life-threatening conditions. Image courtesy of qimono at pixabay.com.

FDA 52

FDA Documentation Communication 52

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 62

Chemotherapy Documentation Hospitals 62

pharmaphorum

DECEMBER 19, 2022

A Member of the European Parliament since 2019, she stated that what happens in a crisis is that existing inequalities get exaggerated. There were communication and psychology problems, he explained, and documentation was scarce or missing. Fitzgerald opened the discussion.

Documentation 83

Documentation Hospitals Communication Vaccines 83

The Checkup by Singlecare

DECEMBER 28, 2023

Some providers may require lab tests or documentation of previous weight loss efforts. When you speak with your healthcare provider, you can discuss any required documentation together and determine whether you meet the conditions for coverage.

Insurance 104

Insurance Insurance Coverage FDA Documentation 104

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 FDA Law Blog

JULY 10, 2023

Performance Metric FY 2018 FY 2019 FY 2020 FY 2021 FY 2022 Average Number of FDA Days to MDUFA IV Decision 72.62 In this case, the FDA clock start date is determined as the date of receiving the submission by the Document Control Center (DCC). Attachment number) and document name or description as appropriate.

FDA 75

FDA Documentation Packaging Communication 75

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 113

Documentation Pharmaceutical Companies Pharmaceutical Companies Hospitals 113

The Checkup by Singlecare

DECEMBER 1, 2023

The FDA maintained this stance in 2019 after its Food Advisory Committee (FAC) reviewed the available evidence on color additives like Red 40 and their impact on children’s behavior.

Labelling 52

Labelling FDA Documentation 52

pharmaphorum

FEBRUARY 10, 2021

The book consists of 208 pages featuring insights and recommendations from 40 leading experts in the field who also participated in the “ Digital Therapeutics for Italy – #DTxITA ” working group, established in 2019.

Documentation 52

Documentation 52

PQA

AUGUST 8, 2022

Between 2019 and 2021, PQS has significantly contributed to the industry’s further understanding of how to utilize pharmacy as a clinical practice by helping to bring awareness of the impact pharmacy staff can have on their communities.

Independent Pharmacies 52

Independent Pharmacies Community Pharmacies Patient Care Vaccines 52

The FDA Law Blog

MAY 8, 2023

a) , and related guidance documents (e.g., Post-market, manufacturers can make modifications consistent with the PCCP and document the modification in accordance with their quality system, without the need for a new marketing submission. See 21 CFR 807.81(a)(3) a)(3) and 21 CFR 814.39(a)

FDA 98

FDA Documentation Labelling 98

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Stellpflug S.J., & Kerns II W (2019). Intensive care medicine , 33 (11), 2019–2024. Greene et al., units/kg/hr) Euglycemia was maintained using 5-10% dextrose infusions. Potassium concentrations < 3.5

Packaging 52

Packaging Documentation 52