European Pharmaceutical Review

OCTOBER 24, 2022

However until now, prescribing a treatment for children with ADHD has been off-label or unlicensed in the UK. AGB-Pharma , the Swedish pharmaceutical company that produced the drug, predicted around 60 percent of all melatonin prescriptions are dispensed to under 18s off-label or unlicensed.

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pharmaphorum

OCTOBER 12, 2018

Digital technology is transforming the way that healthcare is practiced and delivered, with areas like digital therapeutics forging ahead to complement traditional medical approaches and augment patient care.

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Omnicell

JANUARY 10, 2023

It's imperative that pharmacy leaders demonstrate how these systems are helping them conveniently deliver high-quality medications, supporting critical patient care needs with precision and speed. Cone Memorial Health to reduce errors while providing consistent service levels around the hospital's busiest times.

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Hospital Pharmacy Europe

MARCH 21, 2024

2 The first drug produced through printing technology based on inkjet on powder was approved by the US FDA in 2015. The adaptability of 3D printing allows for a rapid response to varying demands, mitigating the impact of shortages on patient care. Pharm J 2022 FDA approves the first 3D printed drug product.

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DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. If the FDA or another regulator requests DSCSA transaction data, the DSCSA regulations give you up to 48 hours to respond. The original article can be found HERE.

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The Checkup by Singlecare

MARCH 30, 2023

For example, over-the-counter hearing aids are now FDA-approved—is your pharmacy stocked and ready? This is an opportunity to educate yourself and your staff on new technology and patient care initiatives. While you’re at it, look at the signs hanging up around the pharmacy and patient waiting area.

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Drug Topics

JUNE 26, 2025

Mifepristone Reduces HbA1c in Patients With T2D, Hypercortisolism | ADA 2025 / Carl - stock.adobe.com Data from CATALYST ( NCT05772169 ) showed that mifepristone met its primary endpoint of reduction in HbA1c compared to placebo at 24 weeks. The study also showed the therapy’s safety profile was consistent with its current label.

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PharmaShots

APRIL 5, 2023

neovascular (wet) AMD Additionally, the availability of Byooviz could enable more patients to access this type of vision-saving therapy as it brings a sustainable and cost-effective anti-VEGF treatment to Canadian vision care Byooviz was approved in Canada for the treatment of multiple eye disorders.

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Viseven

NOVEMBER 17, 2022

They provide information about the following: Off-label usage Publications Safety information Independent medical education. There are also additional responsibilities of these teams, which include : Conducting non-registered clinical trials after the FDA approval of a drug. What do medical affairs teams do? .

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Pharmacy Times

JUNE 20, 2025

Kalis, PharmD, BCOP Key Takeaways Oncology pharmacy's complexity outpaces the generalist model, necessitating specialization for effective patient care and operational efficiency. Image credit: NDABCREATIVITY | stock.adobe.com And the complexity is not limited to clinical care. Carlstrom, PharmD, BCOP , Joseph A.

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pharmaphorum

FEBRUARY 5, 2021

The FDA has said it will wait for additional results from last week’s trial showing an increased risk of cardiac side effects with Pfizer’s arthritis blockbuster Xeljanz before deciding on further action. The post FDA holds back from action over Xeljanz safety study appeared first on.

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The FDA Law Blog

NOVEMBER 29, 2022

Before starting opioid therapy for subacute or chronic pain, clinicians should discuss with patients the realistic benefits and known risks of opioid therapy, should work with patients to establish treatment goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks.

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pharmaphorum

JANUARY 29, 2021

JAK inhibitor Xeljanz is one of Pfizer’s top-selling drugs, despite a ‘black box’ warning for blood clots and cancers added to its label in 2019. Now, a study designed to prove its safety has achieved the opposite. There were however warning signs all wasn’t well with the trial.

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pharmaphorum

SEPTEMBER 25, 2020

The new data – presented at this year’s ESMO meeting – reinforce the massive improvement in patient care that Keytruda has achieved in previously-untreated NSCLC, which had a five-year survival rate of just 5% before the drug was approved in 2016.

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ISPE

OCTOBER 27, 2022

Digital health is transforming the health care landscape through new technologies and platforms in patient care management, conducting of clinical trials, patient data collection, and the diagnosis and treatment of disease. Challenges & Opportunities in Emerging Digital Health Technologies. Ryan Hoshi. James Wabby.

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ISPE

OCTOBER 27, 2022

Digital health is transforming the health care landscape through new technologies and platforms in patient care management, conducting of clinical trials, patient data collection, and the diagnosis and treatment of disease. Challenges & Opportunities in Emerging Digital Health Technologies. Ryan Hoshi. James Wabby.

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The Checkup by Singlecare

MAY 8, 2024

Healthcare providers call upon Remicade for patient care if they fall into the moderate to severe categories. Because the drug suppresses the immune system, the FDA warns specifically about the risk of serious infections, such as tuberculosis and fungal infections.

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Pharmaceutical Technology

MARCH 16, 2023

Barry DeCoster, PhD, an associate professor of bioethics at the University of Michigan, describes gender affirming care as “safe and effective” for most patients. Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care.

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Drug Topics

JUNE 12, 2025

The FDA approved a label expansion for glecaprevir/pibrentasvir (Mavyret) to treat acute hepatitis C virus (HCV) infection in patients 3 years of age and older with compensated cirrhosis or without cirrhosis, AbbVie announced in a release. 3 READ MORE: Infectious Disease Resource Center Pharmacy practice is always changing.

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Pharmaceutical Commerce

JUNE 17, 2025

Intelligent medication management systems using RWD help hospitals forecast demand, respond to crises, and minimize medication expiration and loss, ultimately improving patient care and operational efficiency. The FDA oversees over 23,000 prescription drug products approved for marketing in the US 1 and ultimately, an estimated 361.3

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The FDA Law Blog

NOVEMBER 6, 2024

Koblitz — The fight between Jazz, Avadel, and FDA over narcolepsy drug sodium oxybate has been a long and arduous one. Jazz argued that FDA’s determination was a violation of the Administrative Procedure Act on several fronts. Avadel intervened, and both FDA and Avadel refuted these assertions. This case followed.

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