The Thyroid Pharmacist

AUGUST 1, 2025

Funny enough, in July 2017, on my 35th birthday, I told my husband I was ready to start a family, and went to a naturopathic clinic a few weeks later to get my labs done to prepare for pregnancy, when I realized my period was late! Updated January 31, 2017. 2017 May;12:188-198. Epub 2017 Mar 15. 2017 Sep;27(9):1212].

Health and Personal Care Stores

FDA Law Blog: Biosimilars

JANUARY 9, 2025

As part of the Food and Drug Administration Safety and Innovation Act (known as FDASIA) and later under the FDA Reauthorization Act of 2017 (known as FDARA), a drug or medical device can be deemed adulterated if a regulated company delays, denies, or limits an inspection, or refuses to permit an entry or inspection.

Documentation

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

Beckers Hospital Review

AUGUST 1, 2025

He co-founded MacroHealth in 2017 with a mission to streamline healthcare by helping payers navigate a complex network of 2.4 Mr. Chan has led Iodine Software to the forefront of healthcare AI by developing predictive and intelligent tools that dramatically enhance clinical documentation and revenue cycle outcomes.

Insurance Coverage and Processing

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

APRIL 14, 2025

Baumhardt, Principal Medical Device Regulatory Expert In January 2025, FDA posted the 2024 Annual Report concerning the Accreditation Scheme for Conformity Assessment (ASCA) program as required by Medical Device User Fee Amendments of 2017 (MDUFA IV).

Documentation

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. By Véronique Li, Senior Medical Device Regulation Expert — In late June, FDA published five Federal Register notices that caught our eye, particularly for the dates the classifications were first applicable.

Documentation

Beckers Hospital Review

JULY 11, 2025

Mr. Herrman was appointed CEO and president in 2017. Peter’s Health in 2017. Joseph’s Hospital in Breese from 2017 to 2022. Mr. Kleinhanzl has also championed the use of AI documentation tools like Dragon DAX and Dragon Co-Pilot to combat clinician burnout and enhance care delivery. Luke’s in 2017 as COO.

Hospitals

STAT

MAY 6, 2024

Abrams, a frequent commentator about vaping in the news media, including CBS This Morning, CNN, and The New Yorker, coordinated extensively with Juul on public messaging in 2017 and 2018, according to company emails.

Documentation

STAT

DECEMBER 4, 2023

  The document was supposed to help Novak, then the chief executive of CRISPR Therapeutics, navigate a pressing quandary. “We looked at anything and everything,” said Novak, who stepped down as CEO in 2017 but remained on the board until this year.  But which should they target first?

Documentation

STAT

AUGUST 15, 2023

The company — which is a major supplier of non-human primates to corporate, government, and academic research laboratories — received a voluntary request last May for documents dating back to December 2017 about importing non-human primates from Asia, according to a regulatory filing. ( See page 42.)

Research Laboratories

STAT

AUGUST 16, 2023

 The company — which is a major supplier of non-human primates to corporate, government, and academic research laboratories — received a voluntary request last May for documents dating back to December 2017 about importing non-human primates from Asia, according to a regulatory filing.

Research Laboratories

FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. It was at this workshop that the agency committed to issuing a draft strategy document, for public comment.

Documentation

European Pharmaceutical Review

NOVEMBER 21, 2022

A study on the surge of new antimicrobial research has shown that despite almost a quarter of a million research papers (227,808) being published on the 12 bacterial families in the World Health Organization (WHO) global priority pathogen list of antibiotic-resistant bacteria from 2017, no new class of antibiotics has gone to market since 1987.

Documentation

pharmaphorum

SEPTEMBER 28, 2022

The nine-company pilot launched in 2017 and is designed to explore a new approach to regulating digital health, based on certifying companies and their internal processes rather than individual devices and apps. The Pre-Cert pilot report. O’Leary said.

Documentation

FDA Law Blog: Biosimilars

DECEMBER 4, 2023

Prescribing Red Flags The government alleged that from at least 2017 to April 2021 Defendants knowingly filled controlled substance prescriptions “that raised obvious ’red flags’ of potential abuse or diversion.” If the pharmacist can resolve it, they must make a record of the resolution. Complaint ¶ 55.

Controlled Substances

FDA Law Blog: Biosimilars

MAY 13, 2024

It was Congress that intervened in 2022, to mandate FDA to issue or revise its 2017 guidance on considerations for the use of RWD and RWE to support regulatory decision-making for devices to clarify its regulatory expectations. This guidance, when finalized, will replace the original version of this document finalized in 2017.

Medical Records

Eye on FDA

AUGUST 10, 2023

The number of press releases issued by FDA during the first six months of the year declined to 101 from the 125 issued by June 30 of last year, the lowest number at mid-year since 2017. In 2018, FDA issued a much larger number of releases – trend that continued through 2022, all years with much larger numbers than were seen in 2017.

Communication

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. A similar trial called Impassion131 of Tecentriq with regular paclitaxel flopped, and even suggested patients treated with paclitaxel alone may have fared better.

Chemotherapy

pharmaphorum

OCTOBER 29, 2020

By 2017, NICE added the Preliminary Independent Model Advice (PRIMA) service. 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 service was used twice in 2017/18, four times in 2018/19 and three times in 2019/20 according to FOI responses from NICE.

Documentation

pharmaphorum

APRIL 6, 2021

A Life on Wheels started out as Ross’ hobby back in 2017 and has been growing steadily ever since. It started as a hobby, just a way of documenting my life as a young man with a disability that I could look back on in years to come,” he says. A resonating hobby.

Documentation

Pharma in Brief

JANUARY 20, 2021

Also on January 18, 2021, the FC issued a new Practice Direction outlining its Document Retention Schedule, including new plans for the destruction of certain archived documents. Gowning for in-person hearings remain subject to the Notice of February 6, 2017. Service of Documents. Document Retention Schedule.

Documentation

Express Pharma

AUGUST 2, 2023

The Government has already made its intent clear in the National Health Policy 2017 about creating the Digital Health Ecosystem and has moved to institutionalising technology adoption in healthcare through ABDM. What are the policy initiatives we need for India to reap the insights of digital health solutions available today?

Hospitals

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

FDA Law Blog: Biosimilars

JUNE 28, 2023

As part of that effort, Accreditation Scheme for Conformity Assessment (ASCA) is designed to reduce FDA review time, reduce and/or remove Sponsor guesswork on documentation to provide in a premarket submission, and improve the quality of testing conducted. The MDUFA V reauthorization converts the ASCA Pilot to a permanent program.

Documentation

Pharmaceutical Technology

FEBRUARY 8, 2023

In 2020, the FDA released a guidance document for the industry with recommendations for sponsors developing gene therapies for rare diseases. This document delved into aspects related to manufacturing, preclinical, and clinical trial design for all phases of clinical development.

Documentation

Pharmaceutical Technology

SEPTEMBER 15, 2022

Bristol Myers Squibb (BMS) documented a 9.1% All top 20 biopharmaceutical companies recorded positive compound annual growth rates (CAGRs) in revenue during 2017–21, with BioNTech (319%) and Moderna (208%) leading thanks to their Covid-19 vaccine franchises.

Vaccines

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. 2017; 55(7):1998-2008. Clin Microbiol Infect. 2021; 27 (2): S1-S21. McDonald CL, Gerding DN, Johnson S, et al. Lancet Gastroenterol Hepatol. 2022; 7(12):1083-1091.

Documentation

Pharma in Brief

MAY 29, 2023

On May 12, 2023, Health Canada announced the release of an updated version of the Guidance Document: Certificates of Supplementary Protection ( CSP Guidance ). Links: Notice: Publication of the Guidance Document: Certificates of Supplementary Protection – Canada.ca Certificate of Supplementary Protection Regulations , SOR/2017-165

Documentation

pharmaphorum

DECEMBER 28, 2022

This review will include key documents such as minutes of management review meetings and quality metrics which will enable them to quickly assess the company’s approach to quality and compliance and the current level of control. She joined NSF in 2017.

Pharmaceutical Manufacturing

RX Note

NOVEMBER 19, 2023

On the other hand, Medical Nutrition Therapy Guidelines for Critically Ill Adults is published by Malaysian Dietitians Association in 2017. This handbook complements the limited info available in Paediatric Protocols for Malaysian Hospitals. There is also a chapter of nutritional support in Critical Care Pharmacy Handbook, 2020.

Hospitals

Pharma in Brief

DECEMBER 3, 2023

Full actions (2017–present). The most significant amendments came into force in September 2017, when the Regulations were completely overhauled (discussed here ). The first section 6 actions under the amended Regulations were started in December 2017 (discussed here ). Where we are now Staying power. Fast-paced.

Biosimilars

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya is an oral medication for multiple sclerosis.

Documentation

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

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. The UK is also unique compared to other countries as remote detailing has risen and continues at close to peak levels. In the US, the trend had already started pre-COVID-19.

Pharmaceutical Companies

pharmaphorum

JULY 27, 2022

Of all products approved by the European Medicines Association (EMA) between 2017 and 2020, 68% are currently available in England, a figure that stands at 54% in Scotland. They show that England was sixth and Scotland tenth out of 13 countries when ranked according to the percentage of new medicines made available to patients.

Documentation