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

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 101

Documentation FDA 101

Hospital Pharmacy Europe

APRIL 25, 2024

Since then, legal defences to prosecution for dispensing errors were introduced in 2018, and updated in 2022 to include hospitals, care homes and prisons. When the original 2016 standards were published, the profession was advocating for the ‘decriminalisation’ of dispensing errors, the RPS said.

Community Pharmacies 52

Community Pharmacies Hospitals Documentation 52

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 108

Documentation Communication 108

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

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 80

FDA Chemotherapy Documentation 80

Pharmacy Friday Pearls

AUGUST 29, 2022

2018 Retrospective chart review at a regional poison center (n=199) Patients identified in database by searching for “Beta Blockers”, and/or “Calcium Channel Antagonists” and “insulin” in the respective fields. mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET.

Packaging 52

Packaging Documentation 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

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 64

Packaging Documentation Hospitals 64

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 109

Hospitals Documentation 109

NF2 BioSolutions

MARCH 16, 2022

I had a large break between those and my next big job, a brain tumour in 2018, that was a JOURNEY. Amy after her surgeries in 2018 and 2021. I’ve been documenting my brain tumour surgery (2/9/21) and recovery over on instagram. That caused a paralysed left arm sadly.

Documentation 52

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

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

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 67

Documentation 67

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 103

Documentation 103

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 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

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 116

Documentation Pharmaceutical Companies Pharmaceutical Companies FDA 116

PQA

NOVEMBER 20, 2023

Ultimately, these measures aim to reduce the use of these combinations of medications in the older adult population, for which serious safety concerns have been documented. Both measures were subsequently implemented into the Medicare Part D Patient Safety Reports in 2018 before moving to the Part D Display page in 2021.

Documentation 52

Documentation 52

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 84

Data Entry Documentation 84

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

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

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

The FDA Law Blog

JUNE 19, 2023

Take for example FDA’s Unified Agenda announcement for ISO 13485 harmonization, which first occurred in the Spring of 2018 and was re-issued until a proposed rule was published in early 2022 (see our post here ). And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

FDA 56

FDA Documentation 56

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 103

Hospitals Documentation 103

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

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

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 79

FDA Insurance Coverage Documentation Insurance 79

The Checkup by Singlecare

SEPTEMBER 22, 2023

continues to impact BIPOC individuals and contribute to documented racial and ethnic disparities in health care. National Heart, Lung, and Blood Institute (2018) Implicit Bias. Black, Indigenous, and people of color (BIPOC) patients , in particular, often face unique challenges in the healthcare system.

Insurance Coverage 52

Insurance Coverage Communication Documentation Compounding 52

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 100

Documentation Labelling 100

Omnicell

JANUARY 10, 2023

The investigation, which included inquiries requesting large amounts of documents and communications from various stakeholders, is largely perceived as a drug industry-friendly fact-finding exercise. 2018: The Centers for Medicare & Medicaid Services (CMS) imposed significant Medicare Part B reimbursement cuts to 340B hospitals.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

The Checkup by Singlecare

DECEMBER 1, 2023

Sources Photostability of organic red food dyes , Food Chemistry (2020) Certified food dyes in over-the-counter medicines and supplements marketed for children and pregnant women , Food and Chemical Toxicology (2020) Color additives questions and answers for consumers , FDA (2018) Background document for the Food Advisory Committee: Certified color (..)

Labelling 52

Labelling FDA Documentation 52

The Checkup by Singlecare

FEBRUARY 1, 2024

There are many other interactions documented with oxycodone. You should stop an MAOI for 14 days before initiating oxycodone or any opiate drug. Examples: Nardil (phenelzine), Zyvox (linezolid) This list of potential interactions is not intended to be all-inclusive. Consult your pharmacist for a complete list of detailed interactions.

Controlled Substances 52

Controlled Substances Documentation Labelling 52

ISPE

OCTOBER 28, 2022

The writing of requirements, design documentation, and test scripts, and the configuration of hardware and software, can be conducted from home. For remote testing, several procedural changes have been made to accommodate the capturing of document approval. Los Angeles, CA, US: Sage Publications, 2018. 6 Denzin, N. 8 Glaser B.

Communication 52

Communication Documentation FDA 52

The FDA Law Blog

FEBRUARY 27, 2023

Helpful practitioner prescribing guidance is set forth in a simplified document here. The Act also established new definitions for “Internet,” “online pharmacy,” “practice of telemedicine,” among others. 21 U.S.C. § 802(54)(D)(i). We will release exciting details of our upcoming webinar addressing telemedicine soon. Stay tuned.

Controlled Substances 59

Controlled Substances FDA Documentation Labelling 59

ISPE

NOVEMBER 3, 2022

Health Canada has been working as part of a consortium since 2018, Hamel said. Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. From three applications in the first year, they are now working on eight.

Communication 98

Communication FDA Documentation Vaccines 98