The Infectious Pharmacist

AUGUST 1, 2021

Unfortunately the only messages about masks, vaccines, and COVID-19 that we’re hearing are: Just when you thought it was safe to go back in the water. And my favorite (this is a family blog so I can’t use profanity): Well that’s great. I’ve tried to be as candid as possible in these blog posts. That’s just f ing great man.

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ISPE

AUGUST 30, 2023

to help facilitate participants in developing a CCS using a case study and supporting documentation from an existing cGMP facility. In a collaborative work environment, they will evaluate facility documentation and draw conclusions to be shared with the workshop team and other participants.

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The FDA Law Blog

SEPTEMBER 10, 2023

Tobolowsky — CDER, CBER, and the Oncology Center of Excellence recently published a final guidance document titled “ Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products ” as another part of its real-world evidence (“RWE”) Program.

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Digital Pharmacist

JUNE 23, 2022

We’ve compiled a few topics within this blog post to help you ensure your patients have a healthy and safe summer season. Summer Travel Vaccinations. With that being said, it is important to promote summer health by reminding patients that some areas require travelers to have certain vaccinations.

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Omnicell

JANUARY 10, 2023

The neighborhood pharmacy’s central role in healthcare has taken on new urgency as they are on the front lines of the national effort to administer the COVID-19 vaccine quickly and safely to hundreds of millions of Americans. Click here to learn more about EnlivenHealth.

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PQA

AUGUST 8, 2022

This guest blog is one in a series by sponsors of the 2022 PQA Annual Meeting on the utilization of the EQUIPP platform to promote performance improvement on medication-related quality measures while engaging transparency between health plans and pharmacies. Sheer et al., References Sheer, R., McCullough, J., Pickering, M., 2021, October 13).

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ISPE

OCTOBER 28, 2022

iSpeak Blog. It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. International Collaboration and Reliance: Regulatory Panel Discussion at the 2022 ISPE Singapore Conference. Trudy Patterson. 28 October 2022.

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PQA

JULY 28, 2023

Transforming Pharmacy Care Beyond the Pandemic Walgreens' Rina Shah discusses how the retail pharmacy segment has changed since the start of COVID-19 and what the future of treatment and vaccines for the virus looks like as regulations begin to change. Learn more in Micah Cost's new blog.

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PQA

JUNE 16, 2023

Additional medical services beyond vaccinations are becoming more routine at pharmacies. See our recent blog. These include testing for HIV, COVID-19 and other conditions; mental health screening; and education on protective health measures. data sources), and usability.

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Documentation Vaccines 40

ISPE

NOVEMBER 3, 2022

iSpeak Blog. Okudaira of PMDA agreed that communications may be a driving force of acceptance of new models, and also establishing international convergence documents may help. A 2020 pilot invited external authorities to participate and observe EMA procedures authorizing COVID-19 vaccines and therapeutics. Trudy Patterson.

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The FDA Law Blog

JANUARY 7, 2024

This review was limited to drugs with approved New Drug Applications (NDAs); biologics and vaccines were excluded. In fact, the publicly available review documents for Zavzpret (zavegepant hydrochloride), Sotyktu (deucravacitinib), and Quviviq (daridorexant) do not identify any data (e.g.,

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ISPE

SEPTEMBER 11, 2023

iSpeak blog. Manufacturing Biological Medicines on Demand: Safety and Efficacy of Granulocyte Colony-Stimulating Factor in a Mouse Model of Total Body Irradiation.” “Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” New Project: Evolutive Vaccines Facility for Sanofi.” iSpeak blog.

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Health and Personal Care Stores Vaccines Packaging Documentation 52

The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. Remarkably, manufacturers may not dispute a CMS notification.

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Vaccines Packaging FDA Documentation 59

ISPE

NOVEMBER 21, 2022

iSpeak Blog. It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Regulatory Panel Discussion on International Collaboration and Reliance. Trudy Patterson. Mon, 11/21/2022 - 15:03. 21 November 2022.

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ISPE

NOVEMBER 22, 2022

iSpeak Blog. Have all requested documents ready and easily accessible. The panel was asked about some of the challenges that inspectors had found when inspecting manufacturers of mRNA vaccines or cell-based medicines. ASEAN Regulatory Roundtable: The Future of Pharmaceutical Inspections. Trudy Patterson. Tue, 11/22/2022 - 06:53.

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Roots Analysis

FEBRUARY 1, 2024

In the absence of suitable temperature controlled packaging solutions, the products packaged, such as vaccines, biologics, cell and gene therapies might get exposed to extreme ambient temperatures. Additionally, they are equipped with sensors / data loggers to monitor and document the product’s temperature throughout the process.

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The Thyroid Pharmacist

NOVEMBER 8, 2024

I started speaking about the connection our stool testing showed between Blasto and Hashimoto’s in 2014, wrote a comprehensive blog about it in 2015, and shared my findings with my Thyroid Mastermind colleagues. Researchers found they could suppress the autoimmune response if using a vaccine or antibiotic that specifically eradicates E.

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