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.

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pharmaphorum

OCTOBER 7, 2021

Use of these platforms was however already trending up before the crisis, and there’s every sign demand will stay high from now on, according to Sjors van den Camp, commercial director at Online Seminar – a company whose heritage in this sector goes back more than a decade. The crisis that changed everything.

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Pharmaceutical Technology

MARCH 6, 2023

Based on preclinical research for their impact on aging, well-known drugs like metformin and rapamycin are already being considered for off-label usage, due to their accepted safety profile and cost-effectiveness. Bellantuono worries that labeling aging as a disease indication could be “agist” and would have social implications.

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Labelling Diabetes Communication Pharmaceutical Companies 145

Pharmaceutical Technology

JUNE 16, 2023

Designated as BG01-2202, this latest trial will be an open-label, randomised, controlled clinical study of UTD1 versus chemotherapy drug docetaxel. This latest study approval follows a previous open-label, multi-centre Phase II trial conducted in China (NCT03693547). as the secondary endpoints. as the secondary endpoints.

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Chemotherapy Labelling Communication Pharmaceutical Companies 52

pharmaphorum

APRIL 15, 2021

As these innovations – which have the potential to be transformative for patients – enter uncharted regulatory territory, the pathway is not always clear or well-defined, which is why Astellas adopts a proactive approach to early communication with health authorities. “We Looking to the future. About Astellas. Astellas Pharma Inc.

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Labelling Communication Pharmaceutical Manufacturing Pharmaceutical Companies 62

RX Note

MARCH 28, 2023

To illustrate, every now and then, I may encounter an off-label indication of medication that I do not know of. It is a cognitive bias that occurs when an individual, communicating with other individuals, unknowingly assumes that the others have the background to understand. Nevertheless, I still miss my free lunch, and free pens much.

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Hospitals Labelling Communication Pharmaceutical Companies 52

Viseven

APRIL 11, 2023

It helps to ensure that the content strategy covers all required interaction channels and opportunities without missing a single bit of communication with target customers. Companies can deliver more relevant and engaging content, improve the customer experience, and ultimately change the customer’s basic perception of the product.

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Pharmaceutical Technology

DECEMBER 22, 2022

As pharmaceutical companies launch their products across European countries, the joint procedure is intended to reduce the duplication of submissions with different evidence requirements and procedural times required at a country level, and thus streamline workflows and reduce administrative burden.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

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GMPSOP

MARCH 20, 2024

After each successful calibration, label the instrument with its calibration status, indicating the date of calibration, the next due date, and the initials of the personnel who conducted the calibration. Effective communication with calibration service contractors and adherence to their SOPs are essential to maintaining calibration quality.

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Documentation Pharmaceutical Manufacturing Labelling Communication 52

GMPSOP

JULY 31, 2023

The FDA sets stringent requirements for operational qualification for critical equipment and systems to ensure the safety and efficacy of pharmaceutical products. These requirements mandate that pharmaceutical companies thoroughly document OQ protocols, testing methods, acceptance criteria, and results.

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Eye on FDA

JULY 7, 2020

In the now distant past, enforcement from this office, then called the Division of Drug Marketing, Advertising, and Communications (DDMAC) and later re-named OPDP, was robust, with the office issuing scores of letters a year (156 were issued in 1998). One of them was about the appropriate use of links.

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Pharma Marketing Network

JUNE 11, 2020

We may do some things like you were talking about where we have advertorials, and it’s clearly labeled as an advertorial. And, you know, in just a couple of weeks since we relaunched, we had about 50, some pharmaceutical companies visiting. Don Langsdorf (EHS): 141 different pharma companies from around the world.

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The Thyroid Pharmacist

OCTOBER 27, 2023

These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Precautions Do not take more than the recommended dose on the label. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria.

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Eye on FDA

MARCH 10, 2021

As an agency, FDA issues Warning Letters from multiple sources covering a span of topics and concentrated on various segments of the subject matter jurisdiction of the agency – from food to devices to cosmetics and of course, to the communication by the manufacturers of medicine about their products. The subject matter was a DTC video.

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The Thyroid Pharmacist

OCTOBER 28, 2022

Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” thingsIlearnedthehardway). May improve immune function : B.

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