Pharmaceutical Technology

JULY 18, 2025

Comstock said it is not yet clear if the report will be turned into an official agency guidance document, but it will be made publicly available. However, the PRV program for rare pediatric diseases is at risk of expiry in September 2026, and is pending renewal.

Drug Development

pharmaphorum

JULY 7, 2025

Skip to main content Monday 7 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

Insurance Coverage and Processing

Beckers Hospital Review

AUGUST 8, 2025

Dr. Arline leads patient safety, quality, analytics, documentation and infection control at BayCare Health System, a 16-hospital network. She launched a comprehensive clinical documentation improvement program, which resulted in enhanced revenue and performance on quality rankings. Laura Arline, MD. Krista Curell, JD, RN.

Hospitals

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

Although the program has not been without its critics (including as documented in two GAO reports from 2016 and 2020 ), there is ample evidence that the program has been successful at accomplishing its goals, which has become more evident with time. Notably, it was reauthorized in 2016 (until 2020) and in 2020 (until 2024).

Documentation

pharmaphorum

AUGUST 6, 2025

Skip to main content Wednesday 6 August 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views (..)

Diabetes

Beckers Hospital Review

JULY 11, 2025

based RWJBarnabas Health, in 2016 as COO and became CEO in 2018. Since becoming CEO of Bristol Health in 2016, Mr. Barwis has driven transformation centered on patient satisfaction, operational excellence and health equity. Mr. Johnson was named president and CEO of LMH Health in 2016. Patrick Ahearn. Kurt Barwis. Steven Edgar.

Hospitals

FDA Law Blog: Biosimilars

APRIL 6, 2025

This opinion, which overrules a Fifth Circuit decision that FDA had acted arbitrarily and capriciously in denying premarket tobacco product applications submitted by manufacturers of flavored e-liquids for open-system e-cigarettes, marks the latest development in the ongoing debate and FDA regulation of flavored vape products.

Documentation

STAT

FEBRUARY 23, 2023

attorney general is specifically looking at “communications with AKF, documents relating to donations to the AKF, and communications with patients, providers, and insurers regarding the AKF.” ” The probe covers everything from January 2016 to the present day. Continue to STAT+ to read the full story…

Communication

STAT

SEPTEMBER 29, 2022

One medical device lawyer wrote that the document “violates” the 21st Century Cures Act passed by Congress in 2016 to exempt certain software products from regulatory review. But they are sharply divided on whether that’s a much-needed change, or a dramatic overreach by regulators.

Documentation

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! Subscribe on iTunes , Android , or Stitcher The CHEST guidelines on venous thromboembolism disease are an invaluable resource, but one flaw that has persisted since 2016 has made referencing the guidelines awkward and inconvenient. Statment 11.2

Documentation

ALiEM - Pharm Pearls

MARCH 29, 2023

Children 29 days or older with fever from a documented viral source can be managed according to their clinical presentation and can go outside the algorithm. This requires a documented positive viral swab and not just a presentation consistent with a viral syndrome. 2016 Aug; 138(2):e20154381. 2016 Jun 1;170(6):624].

Hospitals

RX Note

OCTOBER 9, 2023

Since we don't even remember what we eat this morning, it is vital to make proper medical documentation. The amendments should be documented on the prescription and endorsed with “prescriber contacted” (PC), dated and initialled by the pharmacist/person dispensing. Readable) Use only well-recognized abbreviations. Not be informal.

Documentation

Pharmacy Joe

MARCH 27, 2024

Episode 908: Finally, All the VTE Recommendations In One Document! Subscribe on iTunes , Android , or Stitcher The CHEST guidelines on venous thromboembolism disease are an invaluable resource, but one flaw that has persisted since 2016 has made referencing the guidelines awkward and inconvenient. Statment 11.2

Documentation

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

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

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

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

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

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

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

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.

Documentation

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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