Hospital Pharmacy Europe

APRIL 25, 2024

The Royal Pharmaceutical Society (RPS) has published updated patient safety professional standards to reflect legislative, regulatory and national developments since the standards’ previous iteration in 2016.

Community Pharmacies 52

Community Pharmacies Hospitals Documentation 52

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

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 FDA 131

The FDA Law Blog

DECEMBER 1, 2024

FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” In September 2016, Nippon Fine Chemical received a similar Warning Letter about an attempt to prevent an FDA Investigator from taking photographs.

FDA 67

FDA Documentation Labelling 67

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.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Omnicell 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 57

FDA Labelling Packaging Documentation 57

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

The FDA Law Blog

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 44

Documentation 44

Hospital Pharmacy Europe

FEBRUARY 16, 2023

Nevertheless, despite numerous studies employing a range of different interventions, a 2016 Cochrane review concluded that it was not possible to draw robust conclusions because of the variability in study designs, interventions, results and reported outcomes.

Community Pharmacies 98

Community Pharmacies Hospitals Documentation 98

PQA

DECEMBER 1, 2023

In support of this goal, PQA has performed a review of its bylaws and proposes revisions which modernize and streamline this important governing document. Modernizing PQA's Bylaws PQA’s bylaws were last updated in December 2016.

Community Pharmacies 59

Community Pharmacies Documentation Communication 59

The FDA Law Blog

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.

FDA 104

FDA Documentation Labelling Communication 104

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

The FDA Law Blog

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.

FDA 52

FDA Documentation Labelling 52

IDStewardship

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 299

Medication Guidelines Documentation Labelling Hospitals 299

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

Impact Pharmaceutical Services

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.

Documentation 59

Documentation Process Improvement Compounding 59

The FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” By Holly N. Brevig, Senior Regulatory Device and Biologics Exper & Richard A.

FDA 104

FDA Documentation 104

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

The FDA Law Blog

SEPTEMBER 6, 2022

This Draft Guidance, when finalized, will replace the Final Guidance issued just six years ago (the 2016 Guidance). Changes from the 2016 Guidance. Livornese — FDA recently published a Draft Guidance entitled “Charging for Investigational Drugs under an Investigational New Drug Application: Questions and Answers” (the Draft Guidance).

FDA 52

FDA Documentation Labelling 52

PQA

JULY 28, 2023

Since its inception as a Star Ratings measure in 2016, CMR completion rate has steadily increased.Now Is The Time to Advance MTM Quality MeasurementAs our health care system shifts toward patient-centered and value-based care models, there is a need to advance how we evaluate the quality of MTM services. million to 11 million.To

Documentation 40

Documentation 40

The Checkup by Singlecare

JULY 20, 2024

A 2016 article published in Frontiers in Pharmacology noted that phentermine has similarities with the CNS stimulant dexamphetamine, which is found in ADHD medications like Dexedrine, ProCentra, and Zenzedi. Still, “its effects on ADHD symptoms are not well-documented,” he stresses.

Adverse Reactions 86

Adverse Reactions FDA Controlled Substances Documentation 86

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. Then, in 2016, FDA noted its goal to streamline MDR requirements in the Medical Device User Fee Amendments of 2017 (MDUFA IV) commitment letter. By McKenzie E. Cato & Allyson B.

FDA 57

FDA Documentation 57

The FDA Law Blog

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.

FDA 113

FDA Documentation 113

Hospital Pharmacy Europe

JANUARY 4, 2023

The study included data on 79,658 women in the NHS, 93,932 in the NHS II and 31,440 men in the HPFS (2004-2016), without prior stroke or CHD. During >2 million person-years of follow-up, 3603 incident stroke and 8620 incident CHD cases were documented.

Medical Schools 52

Medical Schools Documentation Hospitals 52

The FDA Law Blog

OCTOBER 5, 2022

The proposed rule is intended to align with current nutrition science, the Dietary Guidelines for Americans 2020-2025 and the 2016 nutrition labeling regulation (which also was intended to align with the Dietary Guidelines for Americans). FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.

FDA 52

FDA Labelling Packaging Documentation 52

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

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

PQA

MARCH 22, 2023

Since its inception as a Star Ratings measure in 2016, CMR completion rate has steadily increased. To encourage and reward high-quality care, PQA’s Completion Rate for CMR measure is part of the Medicare Part D Star Ratings program. data sources), and usability.

Documentation 52

Documentation 52

The FDA Law Blog

FEBRUARY 22, 2023

In 2016 , the agency issued its definitive HF guidance, guide manufacturers through human factors engineering processes during the development of new medical devices, focusing specifically on the user interface. For example, if a critical task is introduced or impacted does that trigger the need for a new 510(k)? By Jeffrey K.

FDA 62

FDA Documentation Labelling Hospitals 62

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

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.

FDA 90

FDA Chemotherapy Documentation 90

The FDA Law Blog

JUNE 19, 2023

And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds. If there is a change in administration, this process will almost surely be halted immediately, unless the current administration abandons the effort on its own, as it did in 2016 (see post here ).

FDA 54

FDA Documentation 54

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

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

European Pharmaceutical Review

JULY 4, 2024

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. The second was crofelemer, Mytesi , an indicator drug for HIV-associated diarrhoea extracted from the blood-red latex of the South American croton tree. 3 Is two too few? BMB Reports. 2017;50(3):111–6.

FDA 103

FDA Documentation Compounding Pharmaceutical Companies 103