STAT

JULY 10, 2024

This document is where the government has in the past rolled out changes to the so-called hospital price transparency rule, but the Biden administration did not address the issue in this edition. Since 2021, hospitals have been required to post the prices they have negotiated with all health insurance companies, as well as their cash prices.

Hospitals 113

Hospitals Health Insurance Companies Documentation Insurance 113

Med Ed 101

JUNE 9, 2021

The post Preparing For The BCMTMS Exam in 2021-2022 appeared first on Med Ed 101. I’m happy with the testimonials that we have received that make me believe we provide the best resources on the market that […].

Documentation 40

Documentation 40

STAT

OCTOBER 4, 2023

At issue is a trial that Amgen is relying upon to win final approval for Lumakras, which the FDA approved on a conditional basis in 2021. But ahead of an advisory panel meeting on Thursday, the agency released documents showing its staff found “potential systemic bias” in the trial.

Documentation 121

Documentation FDA 121

European Pharmaceutical Review

MARCH 13, 2024

The data integrity violations API deviations in the microbiology lab The first deviation – failure to follow and document laboratory controls at the time of performance, and failure to document and explain any departures from laboratory procedures – relates to the lack of data integrity within the microbiology laboratory.

FDA 98

FDA Documentation 98

European Pharmaceutical Review

JANUARY 17, 2023

The figures confirmed that in 2022, the UK remained a global leader in clinical research, with total ongoing trials increasing from 168 in 2021 to 178 in 2022. The number of Phase II/III trials increased from three trials in 2021 to seven trials in 2022. Over 80 percent, increasing from 131 trials in 2021 to 145 in 2022.

Documentation 119

Documentation 119

STAT

DECEMBER 29, 2022

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

Insurance 98

Insurance Documentation FDA 98

The FDA Law Blog

NOVEMBER 6, 2023

A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April 2021 that it would start using them as an alternative to on-site inspections. We should explain what RIEs are. Comments on the guidance are invited.

FDA 103

FDA Documentation Medical Records 103

ISPE

OCTOBER 28, 2022

The 2021 publication of the ISPE Good Practice Guide: Good Engineering Practice, 2nd ed., (GEP Application of engineering change management (ECM), engineering document management, and engineering issue management throughout the C&Q process can significantly reduce time, cost, effort, and risk. through system acceptance and release).

Documentation 98

Documentation 98

European Pharmaceutical Review

NOVEMBER 21, 2022

Study data from Elsevier’s abstract and citation database Scopus, identified that 2,450 papers were published in 2021 on the pathogen WHO identified as most critical, Acinetobacter baumannii (carbapenem-resistant). Enterococcus faecium : 1,246 in 2021 versus 730 in 2017. Neisseria gonorrhoeae : 731 in 2021 versus 478 in 2017.

Documentation 98

Documentation 98

The FDA Law Blog

OCTOBER 18, 2022

Amongst CDRH’s highest prioritized device guidance documents are final versions of the transition plans for medical devices that fall within enforcement policies or that were issued emergency use authorizations (EUAs) during Covid-19 public health emergency (PHE). They are also open to information to include in these guidance documents.

Documentation 52

Documentation FDA Labelling 52

ISPE

MARCH 23, 2023

A True Copy is an exact copy of original documentation that preserves the same content, meaning and attributes of the original. It is an electronic copy maintained in an electronic document management system. This negates the requirement for storage of paper evidence and correct GMP document management of these hardcopy evidences.

Documentation 98

Documentation FDA 98

Pharmaceutical Technology

JULY 19, 2022

Mentions of cloud computing within the filings of companies in the pharmaceutical industry rose 65% between the final quarter of 2021 and the first quarter of 2022. Of the 10 biggest employers in the pharmaceutical industry, IQVIA was the company which referred to cloud computing the most between April 2021 and March 2022.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 98

Pharma Marketing Network

APRIL 30, 2021

At this year’s Reuters Pharma Clinical 2021, I joined over 500 global leaders in clinical research as they discussed many of these issues under the theme, “rebuild clinical trials in the image of patient need.”. How do we increase the diversity of clinical trials?

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

IDStewardship

OCTOBER 28, 2022

Develop a manual or guidance document outlining the goals of the account. This type of document is especially helpful for account management transitions in resident managed accounts. Multiple pharmacy organizations have guidance or best practice documents pertaining to social media use. UKPharmRes. BIDMCPharmRes. MayoPharmRes.

Documentation 246

Documentation 246

pharmaphorum

JULY 6, 2021

Oxford Nanopore is also building up to an initial public offering (IPO) later this year that could reinforce 2021’s position as the best-ever year for UK financing, well ahead of last year’s total tally of £2.81 Source: BIA, Clarivate.

Documentation 141

Documentation Vaccines 141

Pharmaceutical Technology

SEPTEMBER 15, 2022

The top 13 players reported more than 10% revenue growth, with BioNTech (3,834.4%), Moderna (2,199.1%), Pfizer (95.2%) and Regeneron Pharmaceuticals (89.1%) reporting a more than 80% year-on-year (YoY) revenue growth from 2020 to 2021, according to GlobalData’s Pharma Intelligence Centre Companies Database. AbbVie reported a 22.7%

Vaccines 108

Vaccines Documentation Compounding FDA 108

pharmaphorum

SEPTEMBER 2, 2020

The guidance published on the Medicines and Healthcare products Regulatory Agency (MHRA) website is broadly similar to arrangements laid out in a Brexit “no deal” document published last year. Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. “If

Documentation 124

Documentation Labelling 124

European Pharmaceutical Review

SEPTEMBER 2, 2022

The sampling strategy must be supported by sound and properly cited sources whose conclusions must be presented as supportive elements in the study documents. The following four elements of sampling methodology were found to be under-documented in RMM effectiveness studies: Supporting documentation for country/region selection.

Adverse Reactions 96

Adverse Reactions Documentation Medical Schools Packaging 96

The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

FDA 106

FDA Documentation Vaccines 106

Blog: Ask a Student Pharmacist

AUGUST 22, 2024

Despite video documentation of George Floyd’s murder, these longstanding generational injustices still caused many to doubt how just the trial’s outcome might be. Martin, Director Occupational Therapy Program April 27, 2021

Documentation 52

Documentation 52

The FDA Law Blog

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

Blog: Ask a Student Pharmacist

AUGUST 9, 2024

Despite video documentation of George Floyd’s murder, these longstanding generational injustices caused many, especially people of color, to doubt the outcome of the trial. Janice Conway-Klaassen, Director Medical Laboratory Sciences Program April 26, 2021

Documentation 52

Documentation 52

pharmaphorum

DECEMBER 4, 2020

In a separate announcement, rival vaccine firm Moderna said it expected to have between 100 and 125 million doses available globally in the first quarter of 2021. The company said it is still on course to manufacture between 500 million and up to a billion doses of the vaccine globally in 2021.

Vaccines 122

Vaccines Documentation FDA 122

pharmaphorum

OCTOBER 18, 2021

2 And, as of September 2021, there are 22 COVID-19 vaccines in use globally 3 , and over 2.3 And advances in digitalisation could facilitate a move from document-based submissions to data-based submissions, through a cloud platform like the one being developed by Accumulus Synergy. Last accessed: October 2021. Perspect Clin Res.

Vaccines 142

Vaccines Pharmaceutical Companies Pharmaceutical Companies Documentation 142

Hospital Pharmacy Europe

OCTOBER 16, 2024

The 92-page toolkit commissioned by NHS England after the 2021 National Overprescribing Review, which recognised the impact that poorly operated repeat prescribing can have on overprescribing and problematic polypharmacy. Any medicines stopped need to also be clearly documented with a reason for the cessation of therapy,’ it added.

Hospitals 52

Hospitals Community Pharmacies Documentation 52

Pharmaceutical Technology

JUNE 28, 2022

Mentions of robotics within the filings of companies in the pharmaceutical industry fell 22% between the final quarter of 2021 and the first quarter of 2022. Of the 10 biggest employers in the pharmaceutical industry, J&J was the company which referred to robotics the most between April 2021 and March 2022. of all sentences.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Omnicell Documentation 52

Druggist

MAY 6, 2021

The official guide on type-2 diabetes management: document produced by NICE for healthcare professionals in the UK, which recommends treatment for type-2 diabetes. . By far, the most widely used sulfonylurea in the UK is gliclazide (OpenPrescribing.net, 2021). Available at: [link] Accessed on 04/05/2021. eMC (2021).

Documentation 98

Documentation 98

pharmaphorum

FEBRUARY 10, 2021

Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. But while amending processes and documentation to suit the 2021 code won’t be easy, the task doesn’t have to be as overwhelming as it first appears, she said.

Documentation 111

Documentation Pharmaceutical Companies Pharmaceutical Companies 111

Pharmaceutical Technology

MARCH 30, 2023

In August 2021, MSD was able to convert Keytruda’s accelerated approval for its use in in patients with locally advanced or metastatic urothelial carcinoma who are not eligible for any platinum-based chemotherapy, into a full approval. As per GlobalData’s consensus forecasts, the drug is estimated to yield global sales of $34.79

Chemotherapy 52

Chemotherapy Packaging FDA Documentation 52

pharmaphorum

MARCH 7, 2022

Last November, it was confirmed that both NHS Digital and NHSX are to be folded into NHS England’s new Transformation Directorate, set up earlier in 2021 with the aim of bringing together digital and operational improvement teams within the NHS. — medConfidential (@medConfidential) November 22, 2021.

Documentation 108

Documentation 108

pharmaphorum

APRIL 28, 2021

Speakers at the 24 May 2021 event entitled ‘True Validation Ready Labeling – What it Really Means’ include Phil Dray, Test Manager at PRISYM ID, and two further independent experts who have long experience in cloud-based systems and regulatory compliance. . . “Yet Experts to come together for compliance event .

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

NOVEMBER 2, 2022

Jörg Zimmermann, International Board Chair for 2021–2022 and Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co., ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Past Chair.

Documentation 52

Documentation Compounding Communication FDA 52

pharmaphorum

FEBRUARY 12, 2021

If 2020 was the year that cemented the role of virtual advisory boards and virtual engagement in many forms, then we believe that 2021 will be the year of ‘virtual co-creation’. Well, at least for 2021! But there are many other ways in which a VAB platform can enhance digital interactions and engagements with KOLs and HCPs.

Documentation 59

Documentation 59

The FDA Law Blog

OCTOBER 5, 2022

eSTAR employs targeted questions to collect specific data and information and includes applicable links to regulations, relevant guidance documents, and other resources. With the exception of points 1 and 5 above, these are not different from when the draft guidance came out in September 2021.

Documentation 44

Documentation FDA 44

Pharmaceutical Technology

JULY 12, 2022

In total, the frequency of sentences related to digitalization between July 2021 and June 2022 was 400% higher than in 2016 when GlobalData, from whom our data for this article is taken, first began to track the key issues referred to in company filings. Of the document's 1,091 sentences, eight (0.7%) referred to digitalization.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

The Happy PharmD

SEPTEMBER 15, 2024

Since 2021, pharmacy-related organizations have been addressing stress and burnout in the profession. The stress experienced by community pharmacists compared to those in other settings is well-documented and has been a longstanding issue. Despite this report being from 2021, the issue still hasn’t been resolved.

Documentation 52

Documentation Dosage Communication Insurance 52

European Pharmaceutical Review

JUNE 12, 2024

This randomised, open label-controlled multicentre clinical trial was conducted across 21 sites in Spain from 2021 to 2023. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2021; 27 (2): S1-S21.

Documentation 111

Documentation Labelling Hospitals 111