The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.

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Labelling FDA Vaccines Communication 40

The FDA Law Blog

JULY 7, 2024

FDA regulations define a complaint expansively, to include “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.” [2] establish and maintain adverse event files.” [9]

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Labelling FDA Communication Documentation 64

pharmaphorum

MARCH 15, 2022

The vast majority of societies were able to transition their planned physical events to virtual formats within remarkably short periods of time, and some delivered impressive attendee experiences. Figure 1 What doctors say about virtual events . . And the evolution continues.

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Labelling Vaccines Communication 105

IDStewardship

JUNE 6, 2023

Streamlined Prescription Filling : AI systems can automate prescription filling processes by extracting relevant information from electronic prescriptions, verifying insurance coverage, and generating labels. AI can assist in language translation, improving communication with non-native speakers.

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Patient Care Prescription Filling Hospitals Medication Dispensing 130

The Checkup by Singlecare

OCTOBER 22, 2024

You’ve probably heard the buzz about Ozempic (active ingredient semaglutide), a popular brand name, FDA-approved Type 2 diabetes medication that’s also used off-label for weight loss. By maintaining open communication with your healthcare provider and making necessary lifestyle adjustments, you can stop taking Ozempic safely.

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Labelling Communication FDA 105

pharmaphorum

NOVEMBER 29, 2022

However, Science Magazine and STAT have reported two different patient deaths in the trial, based on not-yet-public adverse event reports and interviews with people familiar with the trial. STAT reported last month that a male patient died in June of a cerebral haemorrhage after taking the drug along with the common anticoagulant Eliquis.

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Communication Labelling 52

pharmaphorum

SEPTEMBER 15, 2020

The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. The mindset that accomplished this needs to be retained,” Jeremy says. About the interviewees.

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Communication Documentation Labelling Vaccines 130

pharmaphorum

OCTOBER 31, 2022

Our approach is to create a strawman schematic of the required model design based on the disease and therapeutic structure, along with a future event audit. Apply a trending and event-based forecast methodology. Then, use events to model how the market will change in the future if, for example, a new product comes to market.

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Communication Labelling 52

The Checkup by Singlecare

MARCH 8, 2024

It is also used off-label for other forms of anxiety, like agoraphobia, panic disorders, and acute vertigo episodes. An FDA drug safety communication described that combining opioids with benzodiazepines like alprazolam has resulted in serious adverse events related to the additive CNS depression contributed by both types of medication.

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Controlled Substances Communication FDA Labelling 97

Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 52

Pharmaceutical Technology

DECEMBER 16, 2022

This submission comprises preliminary findings from a Phase II open-label, single-arm, single-dose, multicentre clinical trial of CNCT19. Cytokine release syndrome and neurotoxicity were reported to be the most prevalent adverse events (AEs) linked to CNCT19. In the trial, 82.1%

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Labelling Communication FDA 59

BuzzRx

DECEMBER 8, 2022

Read the product label and follow the prescription’s instructions carefully. What is the FDA drug safety communication regarding codeine cough medicine? In the same FDA drug safety communication, the agency also recommends against the use of these prescription medicines in breastfeeding mothers due to possible harm to their infants.

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Communication Adverse Reactions Labelling FDA 52

ISPE

JULY 19, 2023

The framework conditions for this VUCA world have become more acute: Pandemics and geopolitical events are causing fragile and complex supply chains to collapse. and management communication strategy. Conclusion The combined conference event brought discussion of these key Pharma 4.0™

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Documentation FDA Labelling Communication 98

pharmaphorum

OCTOBER 4, 2022

The FDA explains that regardless of the complexity of the software and whether or not the software is proprietary, the output or labelling should provide HCP users with adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation.

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FDA Documentation Labelling Communication 105

The Checkup by Singlecare

MARCH 7, 2024

If someone sustains side effects (such as cardiac issues or neurological problems) from excessive doses of Adderall, those would be considered adverse events, not side effects,” Dr. Martinez says. The Adderall drug label shows no reports of adverse effects in a breastfeeding infant, but long-term effects are unknown.

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Dosage FDA Labelling Communication 104

Pharmaceutical Technology

SEPTEMBER 23, 2022

Additionally , loss of hearing at a young age is associated with impaired communication, cognitive impairment, poorer mental health and quality of life. These open-label, randomized clinical trials were done in patients under 18 years of age. Pedmark clinical trials. The therapeutic landscape.

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FDA Communication Chemotherapy Labelling 52

Hospital Pharmacy Europe

DECEMBER 18, 2023

There are often difficulties with adherence from multiple causes including communication difficulties, dysphagia, polypharmacy and adverse drug events. 15,16 A comprehensive assessment of potential DDIs is strongly recommended, particularly at the start of anticancer treatment. Lancet Healthy Longev 2022;3:e617–e627 Mohamed MR et al.

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Chemotherapy Hospitals Labelling Communication 96

Hospital Pharmacy Europe

FEBRUARY 22, 2024

As such, individuals with these genetic variants are at increased risk of adverse cardiac and cerebrovascular events if treated with clopidogrel. As such, individuals with these genetic variants are at increased risk of adverse cardiac and cerebrovascular events if treated with clopidogrel. Introduction to pharmacogenetics.

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Hospitals Patient Care Medical Records Dosage 111

The Checkup by Singlecare

OCTOBER 16, 2023

What Are the Off-Label Uses for Cymbalta? Cymbalta may have several off-label uses in addition to its FDA-approved uses. Migraine Headaches Another off-label use of Cymbalta is for the management of migraine headaches. The medication may help strengthen the muscles that control urine flow and improve overall bladder function.

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Dosage Insurance Coverage Labelling Insurance 52

The Checkup by Singlecare

MAY 4, 2023

Adding notes about the shape, size, and texture of their pills to the medication list can help in the event pills do get mixed up. Understanding the drug label Much of the information you need to know is printed on the label of your medicine. OTC meds usually have a “Drug Facts” label that lists important information.

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Health and Personal Care Stores Labelling Dosage Compounding Pharmacies 52

ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. Special thanks to Ms. LTD Glace Life Technology (Shanghai) Co.,

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Adverse Reactions Packaging Communication Labelling 52

ISPE

MARCH 28, 2023

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. Special thanks to Ms. LTD Glace Life Technology (Shanghai) Co.,

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Adverse Reactions Packaging Communication Labelling 52

The Checkup by Singlecare

APRIL 2, 2024

In cats, it is used off-label for chronic pain management , anti-anxiety treatment, as well as a seizure medication. Perrin Heartway, DVM and traveling holistic veterinarian, says, “ Veterinarians prescribe gabapentin for cats to help them through stressful events, such as trips to said veterinarian or traveling in general.”

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Adverse Reactions Communication Dosage Labelling 52

The Honest Apothecary

AUGUST 12, 2022

lt means that acknowledging a special event in someone’s life (a birthday, marriage, accomplishment) is more important than submitting my end of month financial paperwork on time. But it tends to communicate that you don’t trust your manager if you are regularly meeting with his/her direct reports with an agenda of your own.

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Labelling Communication 52

The Checkup by Singlecare

DECEMBER 12, 2023

Recognition of these next-day events has led to greater caution with the drug’s use and dosing, and just as important, concerns involving side effects have called attention to drug interactions that can escalate adverse reactions. The Food and Drug Administration (FDA) even sent a special communication to call attention to this risk.

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Adverse Reactions Controlled Substances Labelling Communication 52

The FDA Law Blog

OCTOBER 10, 2023

Labeling and Implant ID Card Lastly, it is critical that patients are provided with implant information as it pertains to their devices. separate patient labeling). FDA also recommends the implant ID card provide contact information in the event of malfunctions or adverse events.

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Documentation FDA Labelling Communication 45

The FDA Law Blog

SEPTEMBER 22, 2024

After a lab submits an MDR, FDA said that laboratories should save the electronic “Acknowledgement 3” (Ack3) generated after submitting an MDR in the MDR event files. This callout is notable as FDA recently issued its first Warning Letter citing a manufacturer for failing to save these electronic acknowledgements in MDR event files.

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FDA Labelling Communication 64

Roots Analysis

DECEMBER 10, 2023

Philips responded by updating instructions and labeling for all affected CPAP and BiPAP machine masks, explicitly warning about possible magnetic interference and listing metallic implants as contraindications. Users with metallic implants are advised to consult their healthcare providers and switch to non-magnetic masks.

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FDA Labelling Communication 45

pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. Just received this email cancelling my 2nd dose of the Pfizer vaccine. 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 Immunization Medical Schools FDA 59

pharmaphorum

JANUARY 8, 2021

I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why. “We

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Vaccines Immunization Medical Schools FDA 59

The Checkup by Singlecare

OCTOBER 30, 2023

In addition, sertraline is prescribed for several other off-label indications, including binge eating disorder and body dysmorphic disorder, even sexual dysfunction conditions like premature ejaculation. In the event of a sertraline interaction, it is important to seek advice from a healthcare professional as soon as possible.

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Mayo Clinic Communication Labelling FDA 52

The Checkup by Singlecare

DECEMBER 6, 2023

Many drug interactions between metronidazole and other medications occur because of increased side effects of one of the medications, either metronidazole or the other drug In the event of a metronidazole interaction, promptly seek medical advice. Check food labels for inclusion of propylene glycol while on a course of metronidazole.

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Dosage Labelling Communication Hospitals 52

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. So whether you’re an advertiser or an event coordinator or a supplier in the industry, most of them have pretty active blogs. We want to be a resource for them. I mean, everybody is a publisher.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Communication 52

The Thyroid Pharmacist

JANUARY 6, 2023

It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. I assure you, you can get past them.

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Dosage Labelling Communication FDA 122

Colors Make me Happy

APRIL 12, 2021

By healthy modeling, a child learns how to show anger appropriately, how to maintain healthy boundaries, how to recover from mistakes, how to communicate, how to be a being, how to cope with stress, and how to self-love. Drop the labels: You are more than a stereotype. We live in a society that has reduced us to labels.

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Labelling Communication 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients?

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Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients?

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Health and Personal Care Stores FDA HIPAA Communication 52