pharmaphorum

NOVEMBER 11, 2022

Dr Stanley Cohen was sued by Alafi Capital and the Christopher Alafi Family Trust – the only investors in Nuredis – in 2018. The lawsuit claimed he misled them whist persuading them to invest $20 million in the biotech, set up to develop a candidate therapy for neurodegenerative disease Huntington’s disease , in return for a 20% stake.

Documentation 113

Documentation FDA 113

The FDA Law Blog

OCTOBER 30, 2022

Cato — On October 21, 2022, FDA published a draft guidance document titled Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care. This draft guidance proposes updates to FDA’s Breakthrough Devices Program, which is outlined in a separate December 2018 guidance document.

FDA 59

FDA Documentation 59

pharmaphorum

APRIL 20, 2021

NICE’s final appraisal document for Kesimpta will be followed by technology appraisal guidance (TAG) that will pave the way for NHS prescribing in England and Wales. It was backed by NICE for NHS use in July 2018. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

Hospitals 111

Hospitals Documentation 111

pharmaphorum

DECEMBER 8, 2022

She has until 3 March next year to submit documentation to the appeals court, ahead of the scheduled start of her prison sentence on 27 April. The company folded in 2018. Holmes – who was convicted in January – launched an appeal against her sentence this week, but has not yet revealed the grounds for doing so.

Documentation 111

Documentation Communication 111

European Pharmaceutical Review

JUNE 12, 2024

Since 2018, biotech company Mikrobiomik has been researching, development and producing innovative biological medicines based on the human microbiome. European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2018; 66(5): 645–50.

Documentation 111

Documentation Labelling Hospitals 111

IDStewardship

DECEMBER 13, 2024

It may be derived from work completed inthe microbiology lab, unitsdispensed from the pharmacy, administrations performed by nurses, expenditures produced from drug purchases, documentation within any area of the electronic medical record, extraction from supplemental tools or data warehouses, and so much more.

Communication 130

Communication Medical Records Documentation 130

pharmaphorum

APRIL 27, 2021

Briefing documents published by the FDA ahead of the meeting suggest that discussion will focus on ongoing trials that may serve as alternative confirmatory studies. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

FDA 90

FDA Chemotherapy Documentation 90

pharmaphorum

FEBRUARY 10, 2021

It will also produce policy documents and information packages for patients, doctors and senior management in companies, Other workstreams could include computational strategies to make such simulations more powerful and efficient, new curricula to educate the workforce on the development and use of the technologies.

Packaging 76

Packaging Documentation Hospitals 76

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 11, 2020

Their findings, published in the September 2018 research report Challenges and Opportunities in Clinical Data Management, underscore the severity of the problem. External and internal audits, when performed, typically reveal source document discrepancies, informed consent issues and lack of drug accountability. Delayed data delivery.

Data Entry 98

Data Entry Documentation 98

pharmaphorum

SEPTEMBER 21, 2020

Waylivra – its second drug – was rejected by the FDA in 2018 on concerns about its safety, including the risk of serious bleeding and low blood platelet count. Fantatic news for the FCS Community – NICE has issued a positive Final Evaluation Document (FED) for Volanesorsen. — Action FCS (@ActionFCS) September 18, 2020.

Documentation 80

Documentation FDA 80

The FDA Law Blog

JANUARY 15, 2024

Importantly, the Court emphasized, “Never in this long, winding, and byzantine regulatory process of meetings, PowerPoint decks, proposed rules, comment periods, guidance documents, and enforcement priorities did FDA ever say that it was contemplating an across-the-board ban on flavored products.”

FDA 115

FDA Documentation 115

pharmaphorum

SEPTEMBER 28, 2020

Veyvondi (vonicog alfa) – originally developed by Shire before the company was taken over by Takeda last year – has been approved in Europe since 2018. However, current treatments are well-established as being safe and effective, according to a CPAG commissioning proposal document published earlier this year. Dr Carolyn Millar.

Documentation 69

Documentation 69

pharmaphorum

DECEMBER 28, 2022

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. In the last 15 years, there has been a noticeable shift towards many prominent players effectively outsourcing innovation to start-ups due to the increasing cost of R&D.

Documentation 119

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 119

pharmaphorum

DECEMBER 8, 2022

The Council has been around since 2018, first meeting on 16 May 2018. 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.

Documentation 105

Documentation 105

The FDA Law Blog

MAY 13, 2024

In fact, in 2018, FDA emphasized that leveraging the use of RWD and RWE in regulatory decision-making is “a top strategic priority for the FDA.” This guidance, when finalized, will replace the original version of this document finalized in 2017.

FDA 111

FDA Medical Records Documentation 111

European Pharmaceutical Review

NOVEMBER 24, 2022

The fourth version was introduced in 2018. Holography can also be integrated with secure web interfaces to help eliminate rogue ordering of products while authorised distributors can pick, pack and ship items in carefully measured quantities to customers, with the product’s movements throughout the supply chain, fully tracked and documented.

Packaging 111

Packaging Labelling Documentation Dosage 111

The FDA Law Blog

DECEMBER 18, 2022

Mullen — On December 9, 2022, FDA issued a draft guidance document on the Voluntary Malfunction Summary Reporting (VMSR) Program for medical devices. In August 2018, FDA published a notice in the Federal Register granting an alternative under 21 C.F.R. By McKenzie E. Cato & Allyson B.

FDA 59

FDA Documentation 59

Hospital Pharmacy Europe

DECEMBER 17, 2024

Right documentation. Policy Research Unit in Economic Evaluation of Health & Care Interventions (EEPRU) 2018. Mayo Clin Proc Innov Qual Outcomes 2018 Nov 26;2(4):34251. Right patient 2. Right medication 3. Right dose 4. Right time 5. Right route 6. Prevalence and economic burden of medication errors in the NHS in England.

Hospitals 52

Hospitals Patient Care Medication Delivery Documentation 52

pharmaphorum

MARCH 18, 2021

This appeal on technical grounds was successful, but nevertheless NICE has published another final appraisal document that still rejects Keytruda. There is also an alternative immunotherapy option in this indication – Roche’s Tecentriq (atezolizumab) – which was recommended by NICE in 2018.

Chemotherapy 52

Chemotherapy Documentation 52

pharmaphorum

JANUARY 12, 2023

For example, there were 12 HCV infections associated with an emergency department nurse at a hospital in Washington in 2018, and 25 gram-negative bacteremia infections in 2011 that emerged in Minnesota.

Hospitals 105

Hospitals Documentation 105

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. The UK is also unique compared to other countries as remote detailing has risen and continues at close to peak levels.

Pharmaceutical Companies 122

Pharmaceutical Companies Pharmaceutical Companies Documentation Communication 122

pharmaphorum

JULY 27, 2022

In addition, the median time between regulatory approval and the first patient receiving a first dose was 247 days in 2020 – an increase of 25 days since 2018. This places England sixth and Scotland tenth of the 13 countries assessed.

Documentation 98

Documentation FDA 98

pharmaphorum

FEBRUARY 25, 2021

Published in January, the document replaces 2013’s UK Strategy for Rare Diseases and sets out four priorities for the next five years: faster diagnosis, increasing awareness among healthcare professionals, the better coordination of care, and improving access to specialist care, treatments, and drugs. “We

Documentation 111

Documentation Labelling 111

The Checkup by Singlecare

JUNE 7, 2023

In a small 2018 study , all 39 participants restricted their calorie intake for 12 weeks. This is one of the most well-documented apple cider vinegar benefits for men and women. A 2018 study also suggested that ACV can help eliminate E. Here are six ways apple cider vinegar might benefit men. But what does the research say?

Documentation 98

Documentation Compounding 98

pharmaphorum

DECEMBER 29, 2022

Plaintiffs – in this case direct purchasers, indirect purchasers and retailers including CVS Health, Kroger, Rite Aid and Walgreens Boots Alliance according to Reuters – filed suit against Novartis and Par in 2018 alleging violation of federal antitrust laws.

Specialty Pharmacies 52

Specialty Pharmacies Documentation FDA 52

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

ISPE

MARCH 20, 2023

Checklist 1 offers detailed guidance by allocating and documenting the responsibilities in the affected processes and overall system context. 2018 ISPE GAMP RDI Good Practice Guide: Data Integrity by Design , Oct. Literature GAMP ® 5: A Risk-Based Approach to Compliant GxP Computerized Systems, 2nd Edition , Jul.

Documentation 97

Documentation Communication 97

pharmaphorum

AUGUST 31, 2021

The US regulator has not only taken a proactive role in exploring the current and future applications of RWD, but also published the framework for its Real-World Evidence Program in 2018, which launched through the 21st Century Cures Act. Furthermore, ECAs are well-documented in the post-approval setting.

FDA 89

FDA Insurance Coverage Documentation Pharmaceutical Companies 89

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

OCTOBER 29, 2020

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. For PRIMA, the agency quotes Peter Wheatley-Price, market access and pricing director at Takeda UK, who said : “The Takeda team highly regarded the quality of the PRIMA reports and model review documentation.

Documentation 101

Documentation 101

The Checkup by Singlecare

AUGUST 8, 2024

A 2018 study revealed that dentists account for 8.6% Garlic Most people love garlic for its versatility in the kitchen, but its medicinal properties appear in documentation as far back as ancient Egypt, Greece, and China. These drugs can help prevent a severe infection from spreading or taking hold after a dental procedure.

Documentation 98

Documentation 98

ISPE

SEPTEMBER 28, 2023

California accounted for 15–18% of patents granted in core life sciences applications between 2018 and 2022. The sub-standard heights were discovered during the initial document review and site assessment. The state of California has a distinct set of assets that have driven growth in the life sciences industry.

Hospitals 98

Hospitals Documentation Pharmaceutical Companies Pharmaceutical Companies 98

pharmaphorum

OCTOBER 18, 2021

The final appraisal document for Dupixent (dupilumab) has given the green light to use of the drug as an add-on maintenance therapy for people aged over 12 with severe asthma characterised by type 2 inflammation and uncontrolled using standard drugs.

Documentation 52

Documentation 52

pharmaphorum

JANUARY 4, 2022

It eventually folded in 2018. She admitted using pharma company logos – including Pfizer – on Theranos documents sent to investors, even though they had not endorsed the technology.

Documentation 52

Documentation Communication FDA 52

pharmaphorum

MARCH 4, 2021

Lilly’s drug becomes an oral alternative to Sanofi and Regeneron’s biologic therapy Dupixent (dupilumab), which was recommended as a second-line option for moderate to severe atopic dermatitis in 2018. Dupilumab does not always work, and some people stop taking it because of side effects,” according to NICE’s technical appraisal document.

Documentation 52

Documentation FDA 52

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. Even if it did not result in an RTA designation, time spent chasing down purportedly missing items (when they were included) could be better spent on substantive review.

Documentation 45

Documentation FDA 45