ISPE

JULY 7, 2023

He is currently co-leading the team working on an ISPE guidance document addressing Pharma 4.0™. We developed recipe management and manufacturing software which controlled and documented these processes.” ™ in 2015 as a “plug and produce” concept to bridge the automation concepts found in Industry 4.0

Documentation 52

Documentation Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

NOVEMBER 25, 2022

In review documents published ahead of the ODAC meeting, the agency took issue with what it described as marginal efficacy in clinical trials of the drug, high toxicity rates, and concerns about the dose selected for study. Spectrum licensed worldwide rights to poziotinib – excluding Korea and China – from Hanmi in back in 2015.

FDA 98

FDA Documentation 98

pharmaphorum

NOVEMBER 11, 2022

According to court documents, Cohen reached out in 2015 to Moshe Alafi, former general partner at Alafi Capital who he had known for decades – and his son Christopher Alafi, who is the firm’s capital director – to seek investment in Nuredis.

Documentation 103

Documentation FDA 103

ISPE

AUGUST 17, 2023

The digitization of paper forms and documents has been a crucial first step in this process, but now we are seeing a shift towards the electronic generation and management of data. For one, electronic data can be stored and accessed more easily than physical documents.

Documentation 98

Documentation 98

IDStewardship

APRIL 13, 2023

In 2015 a National Action Plan for Combating Antibiotic Resistant Bacteria was released, known as CARB. The most recent CARB addresses the years 2020-2025, building upon the initial one released in 2015. The latest antimicrobial stewardship regulations from The Joint Commission went into effect in January 2023.

Hospitals 236

Hospitals Documentation Communication Patient Care 236

pharmaphorum

MARCH 23, 2021

Safety has been an issue throughout development and in 2012 the FDA put tanezumab on clinical hold because of a class-related issue with joint destruction, which was finally lifted in 2015. Tanezumab is now the most developed of the two remaining drugs in development in the NGF class, in pain caused by osteoarthritis.

FDA 58

FDA Documentation 58

The Checkup by Singlecare

FEBRUARY 28, 2024

In 2015, Pennsylvania became one of 41 states to adopt the Affordable Care Act (ACA) Medicaid expansion. Eligibility for Pennsylvania Medicaid Since adopting the ACA Medicaid expansion in 2015, Pennsylvania has implemented targeted enrollment strategies to help eligible Pennsylvanians gain coverage. million Pennsylvania residents.

Packaging 52

Packaging Documentation Hospitals Insurance 52

ISPE

SEPTEMBER 15, 2022

In 2012, there was a proposal for a complete revision which resulted in a concept paper in 2015. First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. The first draft for comments from industry stakeholders was published in 2017 and generated 6000 comments.

Documentation 97

Documentation FDA 97

pharmaphorum

FEBRUARY 26, 2021

From 2015 to 2017, when the cost of the drug was falling, the three suppliers exchanged information about prices, the volumes they were supplying, and Alissa’s plans to enter the market,” said the CMA.

Documentation 52

Documentation 52

Hospital Pharmacy Europe

MAY 17, 2023

But in its consultation documents, the GPhC said ‘now is not the right time to adopt a multi-year approach’, putting this down to a considerable change in the economic conditions since the proposal was originally made. What about international applicants?

Documentation 97

Documentation Hospitals 97

pharmaphorum

JULY 7, 2021

This ambitious document is a blueprint for how the UK can become a global hub for life sciences and, in turn, a science superpower. “Health and science have never been higher on the agenda and today’s vision document sets a clear ambition for the UK to lead the way. Today the Government publishes the Life Sciences Sector Vision.

Documentation 58

Documentation Vaccines 58

The FDA Law Blog

FEBRUARY 29, 2024

According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. FDA-2015-E-2602, FDA-2015-E-2604, FDA-2015-E-2619, and FDA-2015-E-2615), and concern FDA’s July 23, 2014 Accelerated Approval of NDA 205858 and NDA 206545 for ZYDELIG (idelalisib) Tablets for different uses. Patent Nos.

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. Novartis took ownership of the drug in 2015. The Scottish Medicines Consortium is expected to publish its final advice on the drug later this year.

Hospitals 110

Hospitals Documentation 110

ISPE

SEPTEMBER 8, 2023

We have 19 committees, councils, and working groups that are doing incredible work bringing visibility to the industry’s regulatory challenges and developing solutions that are delivered through ISPE content outlets: webinars, PE magazine articles, iSpeak blog posts, training materials, conference sessions, and ISPE Guidance Documents.

Documentation 91

Documentation 91

Hospital Pharmacy Europe

JUNE 8, 2023

In a 2015 systematic review of registered and published outcomes in randomised trials, researchers found that discrepancies between registered and published outcomes of clinical trials were common. Later work simply re-affirmed this finding.

Documentation 52

Documentation Communication Patient Care Hospitals 52

pharmaphorum

JANUARY 4, 2022

Everything started to unravel however when a Wall Street Journal investigation in 2015 discovered that most of the tests Theranos claimed to perform on its analyser were actually being performed by standard blood-testing machines.

Documentation 52

Documentation Communication FDA 52

Pharmaceutical Technology

AUGUST 26, 2022

Earlier this month, the World Health Organisation (WHO) released a new guidance document with a strategic plan to counter TB on a national level. This guidance is in line with the WHO’s End TB Strategy, which aims for an 80% fall in worldwide TB incidence and a 90% decrease in TB deaths by 2030, compared with 2015.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Documentation 98

Hospital Pharmacy Europe

APRIL 12, 2024

The service was piloted between October 2015 and December 2016 among 270 patients. This left him with extensive deconditioning and multiple morbidities – all of which he has documented in a Journal of Cardiac Failure editorial. After identifying a barrier, Dr Khatib adds, he can work with the patient to overcome them.

Hospitals 83

Hospitals Documentation Patient Care 83

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 FDA 98

Board Vitals - Pharmacist

FEBRUARY 5, 2020

between 2012 and 2015. The benefits offered by advanced level practitioners to practice is well documented as well. The study said, “Most of these specialists were advanced practitioners, physician assistants and nurse practitioners, delivering post-acute care.” or lower.”

Nursing Homes 52

Nursing Homes Hospitals Documentation Patient Care 52

pharmaphorum

APRIL 16, 2021

The longer term impact of 2020 on clinical trial activity, given widely documented pauses on trials, will only be evaluable in coming years. We compared the cumulative number of New Active Substances entering each of the EU4+UK for the first time in 2020 with the average of the same measure in previous years – from 2015-2019.

Pharmaceutical Companies 91

Pharmaceutical Companies Pharmaceutical Companies Documentation Vaccines 91

Hospital Pharmacy Europe

JANUARY 19, 2023

Launching a session devoted to global, regional and national perspectives on AMR, Manjiri Gharat (Chair, FIP AMR commission) traced the history of FIP initiatives from 2015 when the first report 1 was published to the launch of the FIP Commission on AMR. The Hague: International Pharmaceutical Federation; 2015. Claire Jones A et al.

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

The Pharmacist Blog

MARCH 21, 2015

It is March and already my motivation to complete my goals for the year of 2015 has been waning. Even in this blog I document my goals and publicize them to hold myself accountable. It is strange how I felt so much energy and motivation to be productive in January. My energy overall seems to be declining each day.

Documentation 52

Documentation 52

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. 2015: PhRMA won a lawsuit against HRSA regarding orphan drugs. 340B providers expressed significant concern.

Hospitals 96

Hospitals Insurance Omnicell Documentation 96

The FDA Law Blog

OCTOBER 5, 2022

In 2015, FDA issued a Warning Letter to Kind LLC because, among other things, the company labeled products as healthy whereas these products provided more saturated fat per serving than permitted by the regulatory definition. The term healthy, as an implied nutrient claim, was first defined by FDA in 1994.

FDA 52

FDA Labelling Packaging Documentation 52

The FDA Law Blog

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.

FDA 59

FDA Labelling Packaging Documentation 59

ISPE

JULY 5, 2023

Owing to the engagements through the ETP and the addition of key personnel with experience in CM in the petrochemical industry, CDER approved the first regulatory submission incorporating CM for a small molecule drug product in 2015. 3 (2015): 840–49. Published 8 October 2015. 3 (2015): 792–802. 3 (2015): 803–12.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

NOVEMBER 1, 2022

CDER and OPQ (established in 2015) focuses on quality throughout the produce life cycle, but it faces the challenge of the global nature of the industry, he said: over three quarters of API sites are outside the US; over half of finished drug formulation sites are outside the US. FDA Activities in Support of Quality.

FDA 98

FDA Insurance Chemotherapy Documentation 98

The Checkup by Singlecare

JANUARY 25, 2023

Despite medical treatments helping to drop the mortality rate between 2015 and 2019, there’s work to be done in educating the general population about what causes skin cancer and why early detection matters. Of the 99,780 Americans likely to have received a melanoma diagnosis this year, 7,650 are likely to die from it.

Documentation 52

Documentation Insurance FDA 52

The Digital Apothecary

MAY 11, 2018

My Years as an Assitant Professor Luckily (sarcasm) part of going up for promotion includes creating a document a couple hundred of pages long detailing what you did. So a lot of the past few years are fresh in my mind and by annual activity, reports are useful just to document my experiences.

Documentation 52

Documentation Hospitals Patient Care 52

ISPE

JULY 19, 2023

™ started in 2015 at the ISPE Germany/Austria/Switzerland (D/A/CH) “Plug and Produce” workshop in Basel, Switzerland. Then in 2015, ISPE in Europe founded the Special Interest Group (SIG) Pharma 4.0™, Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance?

Documentation 98

Documentation FDA Labelling Communication 98

The Checkup by Singlecare

FEBRUARY 16, 2024

10 potential health benefits of NAC Some of NAC’s uses are time-tested and well-documented, like its efficacy in treating acetaminophen overdose. One small study from 2015 showed that some people who took NAC for four weeks saw decreases in systolic blood pressure and diastolic blood pressure. But it’s not just a long-term treatment.

Immunization 83

Immunization Dosage Packaging FDA 83

ISPE

JULY 6, 2023

Q13 Development Timeline The process of drafting the new guidance document was initiated in earnest in November 2018 when the concept paper 2 and business plan were endorsed. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done.

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52

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. FDA began an initial VMSR pilot program in 2015. By McKenzie E. Cato & Allyson B. In that letter, FDA stated that it would “permit manufacturers.

FDA 59

FDA Documentation 59

pharmaphorum

OCTOBER 30, 2022

The two groups were also separated by a sizeable time difference, with data from the control group ranging between 1990 and 2015, while Study 03-133 started enrolling patients in 2004. Changes in standard and supportive care over the time period could also have skewed the results, said the FDA reviewer.

FDA 52

FDA Documentation Labelling Immunization 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. . As the above document suggests, the evidence for increased risk of cancer came firstly from animal studies. Sola D, Rossi L, Schianca GP, et al (2015).

Documentation 98

Documentation 98

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] 2015; 95-96: 138-58. Interestingly, the Arabic phrase for black seed oil, “Hibbatul barakah,” means “the seed of blessing.” Pharmacological Research.

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Dosage Compounding Immunization Insurance 107