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 76

Hospitals Documentation 76

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

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

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

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

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 68

Documentation 68

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 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 88

Medical Records Documentation Pharmaceutical Companies Pharmaceutical Companies 88

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 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

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

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

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

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 75

FDA Chemotherapy Documentation 75

The FDA Law Blog

FEBRUARY 29, 2024

8,128,929 was submitted on December 8, 2016 (Docket No. FDA-2017-E-5106 ), and concerns FDA’s October 19, 2016 Accelerated Approval of BLA 761038 for LARTRUVO (olaratumab). According to documents in the PTO’s Patent Center, Lilly has not yet filed a response. 8,128,929 [] for [PTE] request under 35 U.S.C. §

FDA 59

FDA Documentation 59

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 56

FDA Documentation 56

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 101

Hospitals Documentation 101

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 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 86

Vaccines Documentation 86

ISPE

NOVEMBER 23, 2022

He closed with a comparison between Canada’s Certified Product Information Document (CPID) and ICH’s Product Lifecycle Management (PLCM) documents. Hertz also stated that FDA is proposing to amend the CGMP requirements of the Quality System Regulations for devices and combination products to align more closely with ISO 13485:2016.

FDA 52

FDA Documentation 52

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

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.

Dosage 107

Dosage Compounding Immunization Insurance 107

The Checkup by Singlecare

APRIL 3, 2023

A 2016 study found the combination of ACV and the blood pressure medication Procardia XL to lower blood pressure in rats better than ACV alone. One higher than normal reading isn’t cause for alarm, but three documented, independent readings that are above the 130/80 range [can confirm] a diagnosis in most instances.”

Dosage 98

Dosage Documentation Immunization FDA 98

The Checkup by Singlecare

DECEMBER 1, 2023

Cleveland Clinic (2023) Seeing red: time for action on food dyes [PDF] , CSPI (2016) The post Red 40 side effects and how to avoid them appeared first on The Checkup. FDA (2023) Is Red Dye 40 safe?

Labelling 52

Labelling FDA Documentation 52

European Pharmaceutical Review

DECEMBER 19, 2023

7 The additional substantial economic benefits that flow from room-temperature storability have also been thoroughly documented. This requires the development of technologies to rapidly produce effective, safe, stable vaccines that can be manufactured and distributed quickly. Curr Med Chem. vander Straeten A, Sarmadi M, Daristotle JL, et al.

Vaccines 102

Vaccines Communication Immunization Documentation 102

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

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. Harlow, Essex, England: Pearson Education Limited, 2016. Saunders, M.

Communication 52

Communication Documentation FDA 52

Hospital Pharmacy Europe

JANUARY 19, 2023

In 2016, the country’s first National Strategic Plan in Antimicrobial Resistance 2017–2021 was published. Accompanying leaflets for patients have been developed and also digital versions of the documentation. Thailand has had a number of projects to promote appropriate use of antimicrobials. By 2021, reductions of 15.2%

Community Pharmacies 98

Community Pharmacies Hospitals Communication Medical Schools 98

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 296

Medication Guidelines Documentation Labelling Hospitals 296

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.

Communication 52

Communication Packaging Patient Care Hospitals 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