The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. After reviewing comments, FDA will revise and move questions and answers to the final document, as it deems appropriate. By Sophia R. Gaulkin — Last week, the U.S.

Documentation 59

Documentation Labelling FDA Packaging 59

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

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

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 117

Documentation FDA 117

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 109

Hospitals Health Insurance Companies Documentation Insurance 109

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

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

Med Ed 101

MARCH 10, 2021

This document […]. The post Heart Failure Guideline Updates in 2021 appeared first on Med Ed 101. Prior to the full guideline release, the organization recently printed their updated Expert Consensus Decision Pathway for treatment of patients with heart failure with reduced ejection fraction (HFrEF).

Documentation 40

Documentation 40

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 125

Vaccines Documentation FDA 125

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

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 105

FDA Documentation Medical Records 105

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

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

IDStewardship

MARCH 12, 2023

Memorizing 45+ page document is certainly not a reasonable expectation, but one can certainly walk away with an awareness of general concepts and themes which are relevant. Article 5: A Baker’s Dozen of Top Antimicrobial Stewardship Intervention Publications for Hospitalized Patients in 2021 Find it here.

Medication Guidelines 299

Medication Guidelines Documentation Labelling Hospitals 299

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

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

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

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 115

Documentation 115

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

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

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

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

Pharmaceutical Technology

JULY 15, 2022

The documents state that a partnership with a CMO would be cheaper than the state directly manufacturing insulin. California’s budget documents give few details about the tender process, but state that CalRx will spend $50 million to partner with a contract manufacturer to develop biosimilar insulin products in vial and pen form.

Insurance 131

Insurance Documentation Packaging 131

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. In this article I’m looking at four 2021 healthcare funding reports: CB Insights, StartUp Health, Rock Health, and Silicon Valley Bank.

Documentation 141

Documentation 141

STAT

JULY 24, 2023

Of 173 drug appraisals conducted by the National Institute for Health and Care Excellence since April 2021, 138 involved patient groups with a financial link to the maker of the drug being assessed, or have since received funding. Financial interests were often not clearly disclosed in NICE documents.

Documentation 87

Documentation 87

pharmaphorum

JUNE 3, 2021

This article appears in our digital magazine Deep Dive: Market Access 2021. And anyone interested in a game of policy bingo will be able to mark off all the important policy documents and every agency too. Leela Barham takes stock. Read below for a preview: NICE has never stood still since it started its work in 1999.

Documentation 98

Documentation 98

European Pharmaceutical Review

OCTOBER 25, 2023

The document by the Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada, contains key guidance on predetermined change control plans (PCCPs) for MLMDs.

Documentation 105

Documentation FDA 105

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

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

pharmaphorum

NOVEMBER 20, 2020

billion doses by the end of 2021. It is one of 11 vaccines that are in phase 3 development, including contenders from Moderna, Novavax and AstraZeneca, according to the World Health Organization’s regularly updated tracker document. Feature image courtesy of NIAID/Rocky Mountain Laboratories.

Vaccines 96

Vaccines Documentation FDA 96

pharmaphorum

OCTOBER 21, 2021

It can be given to patients who have the most debilitating form AHP, with four or more severe attacks a year, according to a final appraisal document from NICE, which reverses an earlier position that the drug should not be made available by the NHS. — British Porphyria Association (@BPA_Porphyria) October 21, 2021.

Documentation 98

Documentation Compounding Hospitals 98

European Pharmaceutical Review

NOVEMBER 15, 2022

Access opportunities in key policy areas created through IGBA’s blueprint: Biosimilars access was acknowledged as one of four key areas in IGBA’s 2021 Biosimilar medicines Access Policy Blueprint , which aimed to enhance regulatory efficiencies for greater access. Enhancing Regulatory Efficiency – greater access.

Documentation 98

Documentation 98

Hospital Pharmacy Europe

DECEMBER 17, 2024

Right documentation. Int J Qual Health Care 2021 Nov 13;33(4). CLMM ensures that, across all stages of the process from prescription to bedside administration, including medication preparation, dispensing and distribution the six rights of medication administration are met: 1. Right patient 2. Right medication 3. Right dose 4.

Hospitals 52

Hospitals Patient Care Medication Delivery Documentation 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

pharmaphorum

JULY 15, 2022

The just-published final technology appraisal document recommends that Vazkepa (icosapent ethyl) can be prescribed to people in England and Wales for adult patients with high-risk cardiovascular disease and elevated levels of triglycerides (1.7 mmol/litre or above) in their blood who are already taking statins.

Documentation 98

Documentation 98

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. WHO is calling for much-needed changes to the global vaccine market to save lives, prevent disease and prepare for future crises.” ” COVID-19’s impact on vaccine access.

Vaccines 98

Vaccines Immunization Documentation 98

pharmaphorum

NOVEMBER 16, 2022

The North Ireland Protocol has been a source of tension between the UK and EU since it came into force at the start of 2021 – and according to one pharma company the end of the so-called ‘grace period’ could result in major issues with medicines supply.

Documentation 105

Documentation 105