COE Integrated Care

MAY 7, 2025

All of us who work in health care share, at least in the abstract, a single mission: to promote health and take care of the ill and injured…But the business of health care—the gigantic system of administrative machinery in which health care is delivered, documented, and reimbursed—keeps us from pursuing that mission without anguish or conflict.

Insurance Coverage and Processing

pharmaphorum

AUGUST 6, 2025

Stakeholders are brought along throughout the process, alleviating them from the burden of the operation by having their needs documented up front. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company

Diabetes

Beckers Hospital Review

JULY 11, 2025

Mr. Klay joined HSHS in 2009, serving in a variety of operational roles including inpatient and outpatient rehabilitation and respiratory therapy. 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. Thomas Kleinhanzl.

Hospitals

EMCrit Project

JUNE 16, 2025

Intubated patients in the ED should have soft, wrist restraints places without the need for arduous, high-risk documentation or sitters Intubation Checklist EMCrit 176 – Updated EMCrit Rapid Sequence Intubation Checklist Awareness during Paralysis EMCrit 331 – Awareness after Resus RSI and ICU Paralysis – It is Unacceptable!!!

Labelling

FDA Law Blog: Biosimilars

APRIL 6, 2025

As a first step, the Court ascertains whether the agency has actually changed an existing policy. Here, the Court found that FDA had not, in fact, changed an existing policy.

Documentation

STAT

APRIL 6, 2023

South San Francisco biotech Genentech on Thursday announced that an internal review of misconduct allegations concerning a landmark 2009 paper co-authored by Marc Tessier-Lavigne, a former top executive at the company and Stanford University’s current president, did not find any evidence of fraud or intentional wrongdoing.

Documentation

STAT

NOVEMBER 17, 2023

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The  The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed  by 2030 , according to FDA briefing documents published earlier this week.

Documentation

PharmaTech

JANUARY 7, 2025

The final guidance is a revision of a policy that has existed in some form since at least 2009, while a separate, draft guidance will accept public comment for consideration for its final version through April 8.

Documentation

ALiEM - Pharm Pearls

JANUARY 22, 2024

Fever was documented to be 102°F and was not associated with any chills or rigors. 2009 Jan;11(1):66-72. A 40-year-old male, tailor by occupation, was brought to the Emergency Department with complaints of high-grade fever for the past 11 days. Infect Dis Clin North Am. 2007 Dec;21(4):997-1011, ix. doi: 10.1016/j.idc.2007.08.002.

Documentation

European Pharmaceutical Review

JANUARY 2, 2024

While advantages to the Quality by Design approach is clear and practical implementation of Quality by Design is encouraged by publication of public guidance documents ICH Q8(R2) – ICH Q14, the industry has not yet fully embraced the QbD approach in Marketing Authorisation Applications (MAAs) for European market approval, the authors noted.

Drug Development

Eye on FDA

OCTOBER 19, 2022

And FDA made tacit acknowledgement of the fact when it held a public Part 15 meeting in April 2009 to put forth a framework for the discussion of regulating social and digital media, with the aim of developing a guidance related to the unique challenges offered up by new media shortly thereafter. In fact, the medium does matter.

Communication

pharmaphorum

OCTOBER 29, 2020

In 2009, NICE was one of the first health technology assessment (HTA) agencies to offer the opportunity for early scientific advice, at a cost. Figure 1: NICE early scientific advice projects, 2009/10 to 2019/20. Since 2009 the agency has added further charged-for services; in 2015 NICE added the Office for Market Access (OMA).

Documentation

pharmaphorum

NOVEMBER 17, 2020

Keith Wilson is a former heart patient who has worked on a voluntary basis, over many years with various organisations and researchers, promoting Public and Patient involvement to enhance the clarity of documentation and participation in Research. Gareth has been with the Clinical Research Network since 2009.

Documentation

Pharmaceutical Technology

OCTOBER 5, 2022

In 2009, former Biogen employee Michael Bawduniak filed a lawsuit claiming that Biogen had violated the False Claims Act and the Anti-Kickback Statute by providing millions of dollars to healthcare providers (HCPs) as an incentive to prescribe three of its multiple sclerosis (MS) drugs.

Documentation

pharmaphorum

DECEMBER 28, 2022

In 2018, over 60% of all new molecular entities came from smaller biopharma firms, compared with just over 30% in 2009. In the last 15 years, there has been a noticeable shift towards many prominent players effectively outsourcing innovation to start-ups due to the increasing cost of R&D.

Pharmaceutical Manufacturing

Eye on FDA

JANUARY 9, 2022

As noted in the past, there are two primary means for understanding the agency’s latest thinking with respect to promotional communications from pharmaceutical companies – the content and pattern of enforcement and the issuance of guidance documents to shed light on the parameters that exist. in November 2009.

Communication

European Pharmaceutical Review

JANUARY 25, 2024

These standardised documents provide meticulously curated and scientifically approved information. Proposal for a Directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC.” Article 63 EMA (29 January 2020).

Packaging

FDA Law Blog: Biosimilars

JANUARY 15, 2024

This story goes back to the 2009 Family Smoking Prevention and Tobacco Control Act, which prohibits manufacturers from selling any “new tobacco product” without authorization from FDA. Nor did FDA give notice that favored product manufactures had to submit robust scientific studies on flavored cigarette products.

Documentation

pharmaphorum

DECEMBER 17, 2020

As the co-founder of the biopharma company, Raab has been focusing on advancing patient care for kidney disease since 2009. While Ardelyx awaits FDA approval for Tenapanor, it is moving forward with regulatory approval internationally and has filed documents with the European Medicines Agency (EMA).

Documentation

pharmaphorum

NOVEMBER 27, 2020

Teva said in a statement: “The Commission started investigating this agreement in December 2009. Examples included a “lucrative” supply contact earning Teva at least five million euros in profits, even though Cephalon could cover its needs without the additional supplies.

Packaging

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Gilenya is an oral medication for multiple sclerosis.

Documentation

Syner-G

AUGUST 21, 2022

In 2009, IMPACT (now part of Syner-G BioPharma Group) was contracted by a mid-size global pharmaceutical company to prepare 2 Phase 3 clinical study reports (CSRs) for a biologic agent for the treatment of Crohn’s disease. Download a PDF of this case study. Establishment of a Long-Term Medical Writing Partnership.

Documentation

Eye on FDA

JULY 7, 2020

The agency had never said that this was not a permitted practice and only made it clear by issuing the letters, rather than having enunciated the parameter through a guidance document about digital communications. OPDP has indicated in the past that the use of sponsored links without risk information is a no-no.

Communication

European Pharmaceutical Review

DECEMBER 20, 2023

In October 2023, the European Parliament (EP) proposed revisions to the European Commission proposals with diverging views on various topics set out through two documents. Figure 2: European Commission proposed changes to regulatory data protection periods for non-orphan and orphan drugs (Source: L.E.K) What are the latest amendments?

Biosimilars

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The draft guidance, released on March 5, is open for comments until May 7, after which it will replace an earlier 2009 guidance for the industry.

Drug Development

Ramblings of a pharmacist

FEBRUARY 16, 2022

It’s a well-thought through survey document, but I still have uncertainties about how to answer some of the questions – a part asks how many prescriptions were filled with brands and how many with generics. It’s an invaluable document, even if it isn’t perfect. How much were they?). prescription transaction.

Independent Pharmacies

PharmaShots

JUNE 2, 2023

THYNK assists in patient eligibility & pre-approval checks adding to it medical necessity & documentation checks. Formed as a spin-off into a standalone company in 2019, the firm has a proven legacy as a center of excellency in the healthcare RCM Tech domain since its inception in 2009.

Insurance Coverage and Processing

STAT

OCTOBER 16, 2023

The tobacco industry has already spent the last few months doing everything it can to drum up opposition, from drafting letters for members of Congress to rallying freedom-focused smokers, according to a review of advertising databases, leaked documents, and research reports.

Documentation

Beckers Hospital Review

JULY 25, 2025

Mr. Awan spearheaded the deployment of an ambient AI solution that reduced clinician documentation time by 25%, directly improving provider satisfaction and patient experience. His restructuring of the IT department fostered agility and innovation, aligning technology with institutional research and care goals.

Hospitals

Putting Patients First Blog

JANUARY 10, 2024

9,10,11 The current verification process poses substantial challenges for formerly incarcerated individuals, who often encounter difficulties in securing necessary documentation and employment. These resources should include guidelines on qualifying life events, necessary documentation, and deadlines. Retrieved from https ://w ww.

Insurance Coverage and Processing

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] Published 2009 Mar 10. [15] 2009; 1(2); 143-149. [22] Int J Physiol Pathophysiol Pharmacol. 2009;1(2):143-149. 22] Shokri H. Avicenna J Phytomed.

Diabetes

The Thyroid Pharmacist

JULY 29, 2022

Feel free to use my own health timeline as a guideline to document your health journey. 2009 Oct-Nov;25(9-10):577-81. 2009 Oct;16(5):385-91. As you add your symptoms to a health history timeline, reflect on what season it was when your allergy or thyroid symptoms worsened. 2010;20(7):755-761. doi:10.1089/thy.2010.1636.

Health and Personal Care Stores

The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition. 2009-0041.

Dosage

Putting Patients First Blog

SEPTEMBER 9, 2024

These codes facilitate proper documentation and reimbursement, ensuring that health care providers are fairly compensated for the critical services they offer. The NHC supports the increased utilization of Z-codes to document social risk factors as part of the PIN services. BMJ Quality & Safety, 30 , 356-361. 6 Singh, G.

Insurance Coverage and Processing

pharmaphorum

JULY 10, 2025

Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. Website and content copyright © 2009- 2025 , pharmaphorum media limited or its licensors; all rights reserved. pharmaphorum – an EVERSANA company The rights of trademark owners are acknowledged.

Diabetes

European Pharmaceutical Review

MAY 8, 2025

The document outlines alternative approaches to animal testing, including Threshold of Toxicological Concern (TTC), Quantitative Structure Activity Relationship (Q)SAR), Read Across Approaches (RAX), and in vitro approaches. December 2009. CPMP/ICH/2738/99. EMA/CPMP/ICH/286/1995. 15 November 2018. EMA/CHMP/SWP/545588/2017.

Compounding

The Thyroid Pharmacist

MAY 12, 2025

25] There have also been documented cases of improved egg quality and spontaneous pregnancies following PRP, both naturally and through IVF. 29] One 2009 study with 26 pregnant women found that those taking 500 mg of L-carnitine during pregnancy, starting at week 13 of gestation through birth, normalized their levels of carnitine. [30]

Immunity