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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Independent Pharmacies FDA Documentation CPhT 52

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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Controlled Substances Customer Service Labelling Patient Care 52

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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FDA Packaging Labelling Patient Care 49

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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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

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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Patient Care Dosage Controlled Substances Insurance 52

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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Labelling Patient Care FDA 135

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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Chemotherapy Labelling Patient Care FDA 75

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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Health and Personal Care Stores FDA Communication Clinic Management 52

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.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

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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Labelling Pharmaceutical Companies Pharmaceutical Companies Communication 144

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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FDA Labelling Patient Care 111