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

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”.

Communication 99

Communication Documentation Patient Care 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.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies Omnicell 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

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 225

Communication Medical Records Documentation 225

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

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 105

FDA Documentation Labelling Communication 105

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 105

FDA Documentation 105

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 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

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

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

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

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

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 115

FDA Documentation 115

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

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

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

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

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 FDA 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

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 90

Adverse Reactions FDA Controlled Substances Documentation 90

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

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

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

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 101

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 59

FDA Documentation 59

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

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] A 2016 study found that TQ was able to eradicate 96.8 2016; 16: 471. link] Published 2016. 2016; 16: 471. percent of Giardia lamblia.

Compounding 116

Compounding Dosage Immunization Insurance 116

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

ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g., Smith, and R. Algorri, M.,

Documentation 52

Documentation FDA Communication Packaging 52