RX Note

JULY 22, 2025

It consolidates and replaces four previous guideline publications: Garis Panduan Kaunseling Ubat-ubatan, 2019 Garis Panduan Pelaksanaan Kaunseling Ubat-ubatan Secara Maya/Virtual, 2021 Topical Preparations Counselling Guide for Pharmacists, 2018 Garis Panduan Kaunseling Methadone. Notably, all disease-specific discussions have been removed.

Patient Counseling

Pharmaceutical Technology

JULY 24, 2025

According to ACRO’s 2025 RBQM survey, 96% of trials now include at least one RBQM component (vs just 53% in 2019), with centralized monitoring and remote oversight becoming standard practice 1. To explore how Zelta can support your organization’s clinical data management needs, download the document below.

Communication

Proxsys Rx

JULY 22, 2025

Upgrade your 340B documentation practices and technology Take every necessary step to ensure the accuracy of your records for 340B patient eligibility and drug dispensing. PROGRAM IMPACT / PUBLIC RELATIONS Thoroughly document the value of your 340B program, both to your health system and to the community you serve.

Specialty Pharmacies

Pharmaceutical Commerce

AUGUST 12, 2025

Sean O’Hearen Key Takeaways High-profile counterfeit medicine cases —from the 2019 Kentucky SURGICEL incident to counterfeit HIV drugs and Ozempic—expose vulnerabilities in the US healthcare supply chain, especially via unauthorized “gray market” channels.

Packaging

Putting Patients First Blog

JUNE 16, 2025

Developers should be required to: Conduct inclusive usability testing with older adults, people with disabilities, caregivers, and individuals with limited English proficiency; Share documentation of feedback collection and integration; and Comply with Section 508 and WCAG 2.1 Incentivizing the use of HL7 FHIR, OAuth 2.0,

Documentation

The Thyroid Pharmacist

AUGUST 1, 2025

Published 2019 Dec 10. Published 2019 Apr 28. 2019 Jul;64(4):443-450. Epub 2019 Mar 18. Published 2019 Sep 12. 2019 Dec 19;17(1):44. New York: McGraw Hill; 2019. [91] Indian J Endocrinol Metab. 2019;23(2):238-241. doi:10.4103/ijem.IJEM_609_18 [30] Croce L, Di Dalmazi G, Orsolini F, et al. 2019;10:853.

Health and Personal Care Stores

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

COE Integrated Care

MAY 7, 2025

This concept for soldiers was then increasingly compared to being a health care worker in the United States which “…occurs when clinicians are repeatedly expected, in the course of providing care, to make choices that transgress their longstanding, deeply held commitment to healing” (Dean & Talbot, 2019).

Insurance Coverage and Processing

FDA Law Blog: Biosimilars

NOVEMBER 7, 2024

Sometimes, though, there is no clear precedent, and the product’s regulatory status falls into an undiscovered country. One less utilized method (and for good reason) to gain more certitude is the 513(g) Request for Information.

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

FDA Law Blog: Biosimilars

JULY 7, 2025

This editorial change began in December 2019 to indicate that the document amends the Code of Federal Regulations.

Documentation

Beckers Hospital Review

JULY 11, 2025

Since his arrival at Atlantic Health System in 2019, Mr. Adams has become embedded within the communities that Hackettstown and Newton serve, leveraging his wealth of knowledge as a community hospital leader. The hospital was named a Top 20 Rural Community Hospital in 2019 and 2018 and won a 2019 Wyoming Hospital Quality Award.

Hospitals

STAT

MAY 1, 2024

The FDA’s months-long internal examination of the LBP yielded a series of documents seen by STAT, including a lengthy review, completed in August 2019, of the Mount Sinai study. The review, which lists consultations with 16 different FDA officials, was scathing.

Documentation

STAT

FEBRUARY 15, 2024

WASHINGTON — A new trove of internal emails and other documents from the e-cigarette maker Juul reveals the company’s extensive behind-the-scenes efforts to promote its interests in Washington — a rare insight into the otherwise opaque methods corporations use to influence the government.

Documentation

STAT

FEBRUARY 20, 2024

health care market , AI founders and investors say regulatory uncertainty is a hurdle, forcing them to build more slowly and meticulously document for fear of potential audits. As they race for a slice of the $4 trillion U.S. That makes it harder to keep up with the tech industry’s breakneck pace, they tell STAT.

Documentation

European Pharmaceutical Review

JULY 17, 2023

New research published in JAMA Health Forum has documented that the US National Institutes of Health (NIH) spent $8.1 billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. This was ~10 percent of reported industry spending. billion (3.3

Documentation

NY Times

JULY 30, 2021

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

Documentation

Express Pharma

JUNE 6, 2024

This update aims to align the guidance with the New Drugs and Clinical Trials Rules, 2019, and has been developed in collaboration with the AEFI Secretariat and IPC-PVPI. The statement further adds that the feedback, along with valid justifications, should be emailed to psur.drugs@cdsco.nic.in.

Vaccines

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. 2019 Mar; 2(3). Biondi EA, Lee B, Ralston SL, et al.

Hospitals

pharmaphorum

JANUARY 18, 2021

In a document outlining the charges against Shafat Quadri, of North Potomac, Maryland the US Department of Justice (DoJ) referred only to “one of the largest pharmaceutical companies in the world” based in New Jersey.

Documentation

pharmaphorum

SEPTEMBER 28, 2022

A new final guidance document that dropped today updates a 2019 draft guidance and clarifies the categories of clinical decision support software that would not be regulated by FDA as a medical device. “I O’Leary said.

Documentation

European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. Implementation of the ICH M10 document The EU date of coming into effect of the core ICH M10 document and the corresponding Q&As was 21 January 2023.

Method Validation

pharmaphorum

FEBRUARY 4, 2021

The experts were also involved in the “Digital Therapeutics for Italy – #DTxITA”, established in 2019 to encourage the implementation of DTx in Italian institutions and healthcare systems. Healthware Group, an international integrated consulting group also based in Italy, contributed to the white paper. “At

Documentation

European Pharmaceutical Review

DECEMBER 21, 2022

1 The European Directorate for the Quality of Medicines & Healthcare (EDQM) also accepted LBP as a new category of medicinal products for the European market in 2019. Therefore, characterisation of the microorganism(s) is of utmost importance to LBP quality documentation.

Documentation

Pharma Pathway

JANUARY 6, 2023

Passed out year: 2019 -2020. Kindly Carry the below Documents with you: . Walk-In Interviews for Freshers On 7th Jan’ 2023 @ Granules India Limited (Gagillapur-Hyderabad). Qualification: Intermediate (M.P.C/ Age: 18 -20 years. Percentage: passed Candidates with Consistent academic record of min 55% in 10th & Intermediate.

Pharmaceutical Manufacturing

Pharma Pathway

FEBRUARY 14, 2023

Working: Corporate Office’ Secunderabad Department: Maintenance (Formulation) -Assistant Manager Qualification: Diploma / B.Tech Experience: 05-08 years (Pass Out: 2019 to 2022) Skills: OSD/ OLD-Manufacturing (Formulation), maintenance management, HVAC, Water System, EHS Knowledge, Air Compressor, Documentation, Vacuum pumps.

Documentation

pharmaphorum

OCTOBER 20, 2020

Documenting the change in pharma’s engagement of HCPs is one thing – predicting where channel mix goes in the future, the most important question, is quite another. There is enough evidence accumulating to predict that the commercial model of the 2020s will not be a return to 2019, with COVID-19 a “blip”.

Pharmaceutical Companies

Pharmaceutical Technology

APRIL 24, 2023

The draft guidance is open for feedback from consultees after which the document and its recommendations will be used to establish the organization’s guidance on the use of this combination regimen for patients in the UK’s National Health Services.

Documentation

pharmaphorum

AUGUST 18, 2022

Endo’s slide into bankruptcy follows in the footsteps of Purdue Pharma – which filed in 2019 but is still negotiating opioid settlement and corporate restructuring terms – as well as Mallinckrodt which emerged from chapter 11 after agreeing a $1.6 billion settlement earlier this year. .” Pharmacy chains ordered to pay $650m.

Documentation

European Pharmaceutical Review

NOVEMBER 18, 2022

The document showed that in 2021, approximately 16 billion vaccine doses, worth $141 billion, were supplied across 47 vaccines and 94 manufacturers. This is almost three times the 2019 market volume (5.8 billion), nearly three-and-a-half times the 2019 market value ($38 billion).

Vaccines

pharmaphorum

OCTOBER 29, 2020

Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Figure 2: NICE OMA safe harbour meetings, 2016/17 to 2019/20. The service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE. The NICE-CADTH service was launched in 2019. What is the impact?

Documentation

FDA Law Blog: Biosimilars

JANUARY 15, 2024

FDA published a June 2019 guidance , which stated that manufacturers would not need to perform long-term studies or submit long-term data in PMTAs. At an October 2019 Meeting , FDA explained the application process and provided assurances that decisions would be made on each specific product in a submission—not the submission in its entirety.

Documentation

pharmaphorum

FEBRUARY 10, 2021

While the foundations remain the same, the updated code, which comes into force on 1 July, is structured differently to the 2019 version. Pharmaceutical companies will need new standard operating procedures (SOP) to cover activities such as collaborative working, and new documentation to reflect changes in language. Change management.

Documentation

Pharmaceutical Technology

MARCH 30, 2023

One route to more engaged patients is clear, accessible information – but clinical trial documentation is often highly technical and full of jargon. Plain language summaries simplify clinical trial documentation, using language that any non-expert could understand. So why are so many clinical trials falling short of enrolment targets?

Documentation

pharmaphorum

SEPTEMBER 6, 2021

Now, it reached an agreement with creditors that would increase that settlement payment to $1.725 billion, which will be paid into a trust that will be used to support people whose lives have been affected by opioid use, according to documents submitted to the Securities & Exchange Commission (SEC).

Documentation

European Pharmaceutical Review

NOVEMBER 15, 2022

Validation projects have often been documentation-focused exercises, more befitting a grammar exercise than artifacts supportive of regulated activity. The GAMP 5 Second Edition guide emphasises that focus should be on value-adding activities rather than documentation for documentation’s sake.”

Documentation