PhRMA

JANUARY 25, 2023

This report is the latest to document this progress. One study found, between 2000 and 2016 alone, new cancer medicines were associated with nearly 1.3 The report notes the continued decline in death rates since 1991, including a 1.5% million averted cancer deaths across the 15 most common tumor types.

Documentation 111

Documentation 111

pharmaphorum

JUNE 8, 2022

Users can also use the built-in health records feature on the Health app to download current medications, said Ricky Bloomfield, a former director of mobile strategy at Duke University who joined Apple as clinical and health informatics lead in 2016 in a tweet.

Documentation 131

Documentation Labelling 131

Pharmaceutical Technology

MAY 18, 2023

Within the 14-page document , published by an EMA special task force, are 10 recommendations of best practices that “marketing authorisation holders, wholesalers, distributors, and manufacturers can consider adopting to ensure continuity of medicinal product supply and reduce the impact of shortages”.

Online Pharmacies 99

Online Pharmacies Communication Documentation 99

Pharmaceutical Technology

JULY 19, 2022

In total, the frequency of sentences related to cloud computing between April 2021 and March 2022 was 133% 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 1,422 sentences, 19 (1.3%) referred to cloud computing.

Omnicell 98

Omnicell Pharmaceutical Companies Pharmaceutical Companies Documentation 98

European Pharmaceutical Review

JANUARY 19, 2023

The final appraisal document (FAD) recommended the triple regimen as an option for adult patients who have received two or three lines of therapy. The National Institute for Health and Care Excellence (NICE) has recommended Ninlaro ® (ixazomib) with lenalidomide and dexamethasone for treating relapsed/refractory multiple myeloma (RRMM).

Hospitals 96

Hospitals Documentation 96

pharmaphorum

MARCH 7, 2022

In a letter to the BMJ, Kingsley Manning – who headed NHS Digital between 2013 and 2016 – said that the move is a “grave error” that could threaten the confidentiality and use of patient data. ” “NHS Digital was established to provide at least element of protection,” writes Manning.

Documentation 115

Documentation 115

FDA Law Blog: Biosimilars

APRIL 25, 2023

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Note that section 3060(a) of the 21st Century Cures Act in 2016 amended section 520 of the FD&C Act and removed certain software functions from the statutory definition of a medical device.

Documentation 105

Documentation Labelling Communication 105

Express Pharma

JUNE 28, 2024

The day concluded with insights into future data and documentation imperatives, highlighting meticulous record-keeping and data management for compliance and quality. Mr Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance, said, “ The Summit has indeed grown from strength to strength since its inception in 2016.

Biosimilars 108

Biosimilars Documentation 108

pharmaphorum

AUGUST 23, 2021

The debacle conjures up the spectre of the government’s last attempt to shake up patient data-sharing – 2013’s Care.data scheme – which suffered from a number of false starts and was eventually shut down in 2016. ” The post NHS data sharing scheme “on hold” as millions opt out appeared first on.

Medical Records 89

Medical Records Documentation Pharmaceutical Companies Pharmaceutical Companies 89

pharmaphorum

JANUARY 29, 2021

When I started in 2016 it was still a very academic field without much industrial interest. On top of this, there are the well-documented manufacturing challenges that come with such a new field. “I Sandy Macrae has served as Sangamo’s president and chief executive officer and as a member of the Board of Directors since June 2016.

Documentation 145

Documentation Drug Development 145

pharmaphorum

MAY 3, 2022

Gongda Xue (52), a Chinese citizen formerly working at the Friedrich Miescher Institute for Biomedical Research in Switzerland, has been found guilty of conspiracy to steal trade secrets in relation to medicines under development at GSK between January 2010 and January 2016. She was sentenced to eight months in prison in May 2021.

Documentation 69

Documentation 69

Eye on FDA

OCTOBER 19, 2022

Tik Tok was first released in 2016. That did not happen and in fact, it was many years before any draft guidance documents emerged and then there were principally two of them that addressed some of what was discussed in the 2009 framework – on Character Space Limitation and on Correcting Third Party Misinformation.

Communication 89

Communication Documentation 89

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

Pharmaceutical Technology

JUNE 28, 2022

In total, the frequency of sentences related to robotics between April 2021 and March 2022 was as frequent as 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 1,422 sentences, six (0.4%) referred to robotics.

Omnicell 52

Omnicell Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharma in Brief

OCTOBER 29, 2020

These new consolidated FC Guidelines address many of the topics raised in the following earlier FC Notices to the Profession: Case management: Increased Proportionality in Complex Litigation before the Federal Court (June 24, 2015) ; Trial Management Guidelines (April 2017) ; Intellectual Property (experimental testing) (May 12, 2016) ; and.

Documentation 52

Documentation 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. In 2016, the agency was criticised by the US Government Accountability Office (GAO) for not gathering enough post-marketing data on drugs granted expedited approvals.

Chemotherapy 90

Chemotherapy Documentation Drug Development 90

Pharmaceutical Technology

AUGUST 9, 2022

In total, the frequency of sentences related to artificial intelligence 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 2,465 sentences, 24 (1%) referred to artificial intelligence.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

JULY 5, 2022

Mentions of the future of work within the filings of companies in the pharmaceutical industry were 373% higher between April 2021 and March 2022 than in 2016, according to the latest analysis of data from GlobalData. Of the document's 1,725 sentences, seven (0.4%) referred to the future of work.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

Putting Patients First Blog

SEPTEMBER 13, 2024

In 2016, the National Health Council (NHC) launched its Value Classroom , which consists of eight documents, glossaries, and infographics intended to educate patient organizations about important topics in patient-centered value assessment. Patient voices and perspectives should be centered in the development of value models.

Documentation 52

Documentation 52

FDA Law Blog: Biosimilars

JANUARY 15, 2024

In 2016, FDA determined that e-cigarettes and their component parts fell under the term “new tobacco products,” requiring manufacturers of such products to submit PMTAs for FDA review before the Agency would issue a marketing order permitting the legal sale of the product.

Documentation 115

Documentation 115

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Subpart A – General Provisions Subpart A – General Provisions, incorporates by reference ISO 13485:2016 and Clause 3 of ISO 9000:2015 (new § 820.7), and requirements for a quality management system (new § 820.10). The new § 820.10 Under § 820.45, FDA also requires manufacturers to inspect labeling and packaging for accuracy.

Labelling 59

Labelling Packaging Documentation 59

RX Note

NOVEMBER 13, 2023

Registered companies Governed under Companies Act 1965 (companies registered before 2017) or Companies Act 2016 (companies registered since 1 January 2017). Records and documentations should be kept and updated systematically as stipulated by the law. Regulated by Companies Commission of Malaysia ("Suruhanjaya Syarikat Malaysia", SSM).

Community Pharmacies 52

Community Pharmacies Health and Personal Care Stores Documentation Independent Pharmacies 52

FDA Law Blog: Biosimilars

MAY 22, 2023

CDFA has established a web page with multiple resources for producers and distributors, including links to the regulations and guidance documents. Voters in Massachusetts approved a ballot initiative (Question 3) in 2016 that imposed requirements similar to those imposed under Proposition 12.

Documentation 45

Documentation 45

European Pharmaceutical Review

DECEMBER 23, 2022

To enable this, the design documentation, whitepaper and testing results have been made available open source to all, 6 with the hope that we will see this technology become the standard for buffer preparation as we look to create further efficiencies in the future. . Estimation based on Biosolve v8.3 ‘mAb

Documentation 98

Documentation 98

European Pharmaceutical Review

JUNE 29, 2022

A typical example is the classical biosafety animal testing driven by a collection of guidance documents that often were not revised for decades (eg, ICHQ 5A). London: European Medicines Agency; 2016 [cited May 2022]. However, the biosafety testing strategies rely on outdated technologies that have remained unchanged for decades.

Vaccines 98

Vaccines Documentation 98

Safe Biologics

FEBRUARY 1, 2024

Over the years, the WHO has attempted to evaluate the BQ: a provisional implementation of the programme was suggested in 2016, and in 2017 a pilot BQ project was discussed. Other supporting agencies await the WHO implementing a global system. In 2018, the project was put on hold for data gathering.

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

The Digital Apothecary

APRIL 26, 2019

The authors went back and analyzed much of the past data using previous methods to estimate costs in dollars and reflect inflation for 2016 prices. billion in 2016 US dollars" with a low end of $495.3 Last year I saw a fascinating article by and Watanabe and colleagues about how much medication-related issues impact the US.

Medication Therapy Management (MTM) 130

Medication Therapy Management (MTM) Communication Packaging Hospitals 130

pharmaphorum

JANUARY 12, 2023

From 2010 to 2016, deaths from heroin overdoses increased rapidly, as those in the healthcare community understood the risks of opioid painkillers and reduced the number of prescriptions. The opioid epidemic in the US has been unfolding over the last three decades.

Hospitals 105

Hospitals Documentation 105

pharmaphorum

JULY 27, 2022

These values have seen a year-on-year decline since 2016 for exports and 2015 for imports, in contrast with a general upward trend seen in most comparator countries, said the ABPI. In 2020, exports were valued at $25.9bn, placing the UK ninth out of 20 countries, and imports at $26.8bn, meaning a ranking of tenth out of 20.

Documentation 98

Documentation 98

European Pharmaceutical Review

JUNE 12, 2024

European Society of Clinical Microbiology and Infectious Diseases: 2021 update on the treatment guidance document for Clostridioides difficile infection in adults. 2016; 46: 479–93. References van Prehn J, Reigadas E, Vogelzang EH, et al. Clin Microbiol Infect. 2021; 27 (2): S1-S21. McDonald CL, Gerding DN, Johnson S, et al.

Documentation 111

Documentation Labelling Hospitals 111

ID Stewardship

MARCH 12, 2023

It’s from 2016 about the future of antibiotics and resistance, but it remains highly relevant today and people consistently give positive feedback about it. 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.

Medication Guidelines 119

Medication Guidelines Documentation Labelling Hospitals 119

RX Note

MARCH 14, 2023

Document the antimicrobial therapy in the patient's medical record or medication chart, including the indication and the intended duration of therapy before further review or cessation. Example of patients with altered pharmacokinetics (e.g.

Medical Records 52

Medical Records Hospitals Documentation 52

FDA Law Blog: Biosimilars

JULY 6, 2023

We now see that the proposed rule to “harmonize and modernize” the QSR with ISO13485:2016, creating the new QMSR, is on the Spring 2023 Unified Agenda (see here ). Finally, CDRH would need to ensure alignment on existing guidance documents and regulations that refer to the QSR or 21 C.F.R.

Documentation 52

Documentation Labelling 52

Syner-G

SEPTEMBER 15, 2023

Nonetheless, their rising popularity – eight of the top 10 best-selling drugs internationally in 2016 were biologics – underscores their increasing importance. This documentation supports process control, and optimization, and serves as a regulatory record of reliability and repeatability.

Drug Development 59

Drug Development Documentation Process Improvement Compounding 59

pharmaphorum

OCTOBER 29, 2020

Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20. 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. Source: Data from NICE FOI responses.

Documentation 101

Documentation Drug Development 101

Putting Patients First Blog

APRIL 30, 2024

Key Points of Support Conciseness and Focus of Key Information The NHC supports the FDA’s emphasis on beginning the informed consent document with concise, focused presentations of key information. The importance of using plain language in health communications is well-documented in literature.

Documentation 52

Documentation Communication Mayo Clinic Drug Development 52