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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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

pharmaphorum

AUGUST 27, 2020

Bioindustry association MichBio says the FDA’s labelling requirements for COVID-19 convalescent plasma (CCP) – which were published alongside the emergency use authorisation – could lead to “hundreds, if not thousands, of in-date, ready to transfuse CCP units across the country being rendered unusable.”. The @CDCgov was muzzled months ago.

Mayo Clinic 105

Mayo Clinic Labelling Communication Vaccines 105

pharmaphorum

MARCH 15, 2022

It currently appears highly unlikely that the majority of conferences will simply return to typical face-to-face only formats as they were before 2020. This article summarises the most important lessons learnt during 2020 – 2021. Lessons learnt 2020-2021. Part 2 will assess possible scenarios for 2022 and beyond.

Labelling 105

Labelling Vaccines Communication 105

pharmaphorum

FEBRUARY 5, 2021

billion in the first nine months of 2020, up 10% overall and 23% in ex-US markets. After the ORAL Surveillance data emerged, analysts debated whether the FDA might take action either to remove Xeljanz from the market or – perhaps more likely – update its labelling to reflect the new data and leave prescribing decisions to doctor discretion.

Communication 78

Communication Labelling 78

pharmaphorum

DECEMBER 7, 2020

Wokingham, United Kingdom — 7 December 2020 — PRISYM ID, a leading provider of regulated content and label management solutions for the life sciences sector, announced today that PRISYM 360 version 1.10 PRISYM 360 and SAP technologies communicate through a web service using standard SAP components with no intermediate stages.

Labelling 52

Labelling Communication 52

pharmaphorum

FEBRUARY 26, 2021

Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. And at the tail end of 2020, a $6.5 As with most of the pharma industry, J&J’s financials were hit by COVID uncertainty in 2020, the impacts of which may be felt for years to come. Litigation & controversy.

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Vaccines Biosimilars Labelling Communication 126

pharmaphorum

OCTOBER 7, 2021

Rewind to March of 2020, and pharma companies were facing a communication crisis. Other uses include providing a platform for key opinion leaders (KOLs), as well as internal communications to make sure that messages are unified across an organisation. The crisis that changed everything.

Communication 75

Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 75

Pharma in Brief

NOVEMBER 29, 2020

On November 27, 2020, the Minister of Health (the Minister ) issued the Interim Order Respecting Drug Shortages (Safeguarding the Drug Supply) (the Interim Order ), pursuant to s. The US Importation Rule took effect on November 30, 2020. 1) of the Food and Drugs Act.

Controlled Substances 52

Controlled Substances Labelling Communication Vaccines 52

Eye on FDA

JULY 19, 2021

You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’t surprising given the agency’s role in facilitating treatments, diagnostics and vaccines to respond to COVID. We’ll check in again at year end.

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Labelling Communication Vaccines 93

ALiEM - Pharm Pearls

MARCH 7, 2024

Longitudinal view of the right kidney: Left – Probe placement in right mid-axillary line; Right – Unlabeled and labeled ultrasound view Video 1. Cysts will have a more spherical shape and will not “communicate” with one another [5]. 2020 Jun 8;12(1):31. Transverse view of the right kidney Figure 4. Sibley et al.,

Labelling 177

Labelling Communication 177

RX Note

OCTOBER 5, 2023

Such events may be related to professional practice and healthcare products, procedures and systems, including prescribing; order communication; product labelling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use.

Health and Personal Care Stores 52

Health and Personal Care Stores Labelling Packaging Compounding 52

Pulses

AUGUST 31, 2023

doi:10.1108/IJILT-06-2020-0108 Reiners D, Davahli MR, Karwowski W, Cruz-Neira C. Onime C, Uhomoibhi J, Wang H, Santachiara M. A reclassification of markers for mixed reality environments. Campus-wide information systems. 2021;38(1):161-173. The combination of Artificial Intelligence and Extended Reality: A Systematic Review. 2021;2:721933.

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Medication Dispensing Medication Labelling Packaging Labelling 78

FDA Law Blog: Biosimilars

AUGUST 16, 2023

Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This seems to suggest that FDA expects this type of outcome claim to be included in labeling.

Labelling 52

Labelling Controlled Substances Communication 52

FDA Law Blog: Biosimilars

JULY 10, 2023

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.

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Documentation Packaging Communication Labelling 75

Fuld & Company Blog

FEBRUARY 6, 2023

As a result, HR managers also become detached when communicating with employees. They also rely heavily on historical data and manual labels for training and learning. While employees continue to be ambitious, they increasingly prioritize family, personal time and health. These biases can creep into AI models and their recommendations.

Communication 52

Communication Labelling 52

European Pharmaceutical Review

SEPTEMBER 22, 2023

Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Brain Communications.2022;4(1). Landry I, Kanekiyo M, Aluri J, et al. Lowe SL, Duggan Evans C, et al.

Immunity 97

Immunity Immunization Vaccines Communication 97

The Thyroid Pharmacist

OCTOBER 28, 2022

A 2020 review showed that those with hypothyroidism experience more gut dysbiosis and bacterial overgrowth, marked by notably lower levels of Lactobacillaceae and Bifidobacterium. Another study from 2020 examined the effects of probiotic supplementation on thyroid function in hypothyroid patients. Published January 23, 2020.

Health and Personal Care Stores 105

Health and Personal Care Stores Immunity Immunization Grocery Stores 105

Putting Patients First Blog

JULY 2, 2024

As noted in our previous communications, while the NHC would prefer a more traditional Notice and Comment rulemaking opportunity that would ensure the Agency directly responds to stakeholder feedback, we welcome this opportunity to express our reactions to CMS’ thinking on the negotiation program.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. — Dr Katrina Farrell (@farrell_katrina) December 31, 2020. On the basis of UK government guidance yesterday. This means that the vaccine is not being delivered as licensed. pic.twitter.com/ZDtIjm1z8W.

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Vaccines Immunity Immunization Medical Schools 59

pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. — Dr Katrina Farrell (@farrell_katrina) December 31, 2020. On the basis of UK government guidance yesterday. This means that the vaccine is not being delivered as licensed. pic.twitter.com/ZDtIjm1z8W. Erosion of public trust’’.

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Vaccines Immunity Immunization Medical Schools 59

Putting Patients First Blog

DECEMBER 5, 2024

Real-world case studies demonstrating how PPI has influenced decisions, such as targeted approvals or label modifications, would clarify its practical utility. 17 In addition to its role in pre-market decisions, PPI can be valuable in post-market activities, including the formulation and communication of recall notices. 3 (2011): 3054.

Labelling 40

Labelling Communication Mayo Clinic 40

The Thyroid Pharmacist

JANUARY 6, 2023

I’ve noticed that since 2020, many of us need to do EXTRA to support our mental health. Beyond antidepressants, I’ve seen other mood-altering drugs being used for refractory depression (depression that doesn’t respond to medication treatment), some “off-label,” others with FDA approval. Published 2020 May 11. BMC Psychiatry.

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Dosage Labelling Communication Compounding 122

RX Note

FEBRUARY 23, 2023

Terazosin - Off-label use in ureteral stone(s) expulsion Topical Corticosteroids - Apply thinly on the skin using fingertip unit. Statins - Not all statins need to be taken at night. Human Touch - Why Artificial Intelligence cannot replace us still? Theory in Practice - Life is not ideal but a struggle Life - Why?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58

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.

Health and Personal Care Stores 96

Health and Personal Care Stores Immunity Immunization Compounding 96

FDA Law Blog: Biosimilars

JULY 9, 2024

If FDA determines that a waiver will be issued, it may consider public communications about the decision. Since it is only the submission of the plan that is required by law, how, if at all, will FDA communicate that a plan does not meet the requirements for submission? Some unanswered questions remain.

Drug Development 59

Drug Development Communication Documentation Labelling 59

The Thyroid Pharmacist

OCTOBER 6, 2023

Check food labels carefully, and be extra careful if you are eating out, as it’s difficult to know all of the ingredients used in restaurants. Published 2020 May 14. It may be best to avoid eating out during this elimination period, to avoid any cross-contamination that might skew your results. 2019; 38(1): 152-158. 2018.01.013. [37]

Health and Personal Care Stores 98

Health and Personal Care Stores Immunity Immunization Dosage 98

Eye on FDA

JANUARY 11, 2021

In late March FDA began issuing Coronavirus Updates labeled as a “Daily Roundup” except they weren’t actually always a daily release – some days got skipped. One additional note on FDA’s communications this past year. In all there were 165 of them. The Daily COVID-19 updates were not translated.

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Vaccines Labelling Communication 66

The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In The protocol worked so well for me, I decided to pilot it as a program with a small group in 2020! Published 2020 Jun 9. Front Pharmacol. 2020;11:850. doi:10.3389/fphar.2020.00850;

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Diabetes Immunity Immunization 98

The Thyroid Pharmacist

FEBRUARY 10, 2023

Both our sex and thyroid hormones are part of an overall hormone communications network in our body, referred to as the HPA (Hypothalamic-Pituitary-Adrenal) axis. To date, vaginally-applied DHEA is still only available through prescription, either as Intrarosa® or an off-label customized prescription. Published 2020 Sep 14.

Dosage 98

Dosage Documentation Diabetes Labelling 98

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

Insurance Coverage and Processing 105

Insurance Coverage and Processing Diabetes Labelling Communication 105

Pharmaceutical Technology

NOVEMBER 30, 2022

weight reduction in obese individuals, as per its label. Furthermore, in order to make up for shortages Novo Nordisk’s Ozempic, a version of semaglutide that is approved to treat type 2 diabetes, was used off-label for obese patients. In a Phase II study, CagriSema achieved a numerically higher body weight reduction of 15.6%

Insurance Coverage and Processing 98

Insurance Coverage and Processing Diabetes Labelling Communication 98

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Please check your email to download the Report.

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Documentation Hospitals Dosage Drug Pricing 97

Pharmaceutical Technology

JUNE 1, 2023

After this, patients receiving a placebo were switched to the frexalimab arm and entered the ongoing open-label part B portion of the study. from the $18.9bn recorded in 2020. Researchers observed an 89% and 79% reduction in new gadolinium-enhancing (GdE) T1-lesions for higher and lower doses, respectively, compared to placebo.

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Labelling Communication Immunity Immunization 64