FDA Law Blog: Biosimilars

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 Vaccines Communication 40

pharmaphorum

OCTOBER 7, 2021

If there’s one take-home message about working during a pandemic, it is the enormous value that virtual events, webinars and e-learning can bring when face-to-face meetings and presentations are impossible. Rewind to March of 2020, and pharma companies were facing a communication crisis. The crisis that changed everything.

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Communication Labelling Pharmaceutical Companies Pharmaceutical Companies 75

European Pharmaceutical Review

JANUARY 23, 2023

This has been exacerbated by geopolitical events such as war, the energy crisis and high inflation rates. MSSG stresses the importance of transparency in relation to shortages and highlights the need for all stakeholders to communicate in an objective and responsible way to avoid any undue public concern.

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FDA Law Blog: Biosimilars

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 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

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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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

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

RX Note

OCTOBER 5, 2023

Medication Error The term "medication error" is used to describe any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the healthcare professional, patient or consumer. Use Tall Man lettering Use additional warning labels for LASA medicines.

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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 59

RX Note

DECEMBER 16, 2023

Introduction Medication error is any preventable event that may harm patient. This incident highlights the potential dangers of unconventional medical abbreviations in prescription communication. I did not identify any errors on medication label and the quantity prepared. The prescription was a simple one: T.

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Labelling Dosage Medication Labelling Packaging 52

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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Documentation Labelling Communication 105

Fuld & Company Blog

FEBRUARY 6, 2023

They must collect data including professional aspirations, past performance, career goals, life events, leadership and teamwork traits, motivators, consumption behavior, psychographics, and sentiments related to diversity, equality, inclusion, environment, and sustainability. These biases can creep into AI models and their recommendations.

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Communication Labelling 52

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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Communication Chemotherapy Labelling 52

PharmaState Academy

DECEMBER 12, 2023

. ———————— Compliance in Communication: Significance and Risks NDA stressed the importance of adhering to regulations to prevent financial, reputational, and litigation costs.

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GMPSOP

AUGUST 23, 2022

The tool can also be used for any other quality and compliance issues where a risk event is repetitive and a quality decision is urgent. Is this system used in the creation or verification of product labelling (inserts, outserts, cartons or packaging)? process change, product recall, labelling change, adverse event/safety reporting)?

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Documentation Communication Pharmaceutical Manufacturing Labelling 52

GMPSOP

AUGUST 28, 2023

Raw materials must be inspected to confirm that the containers are intact, have been provided according to the paperwork, and have labels affixed on them identifying the raw material name, batch number, and expiry date. For example, materials with Hold, Quarantine, or Rejected labels must be kept in a quarantine location.

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Health and Personal Care Stores Labelling Packaging Documentation 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

GMPSOP

MARCH 4, 2023

Quality risk management involves the art and science of identifying, analyzing, assessing, and managing uncertain events. Events that can impact product quality or compliance with registered dossier throughout a product’s life. In most cases, these questions need to be asked before a risk event would potentially occur.

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Documentation Communication Method Validation Packaging 52

ID Stewardship

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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Insurance Coverage and Processing Prescription Filling Hospitals Medication Dispensing 52

Quality Matters

AUGUST 3, 2023

ampules, bottles, labels, cartons, shipping containers, desiccants) Services (e.g., This risk assessment effort is not a one-time event but rather a periodic, recurring process for communicating and reviewing risks,” noted USP’s Horacio Pappa, Ph.D., active ingredients, excipients, other raw materials) Packaging materials (e.g.,

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Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

FDA Law Blog: Biosimilars

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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FDA Law Blog: Biosimilars

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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Labelling Communication 64

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.

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Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

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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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 Immunity Immunization Medical Schools 59

RX Note

JUNE 2, 2024

Building Trust for a Thriving Team Our brains are a fascinating combination of the neocortex, responsible for rational thought and communication, and the limbic system, governing our emotions, trust and social behaviour. Each new generation carries a unique set of beliefs shaped by the experiences, events, and technologies of their youth.

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Communication Labelling 52

GMPSOP

MARCH 17, 2023

Immediately communicate the incident to stakeholders and initiate an internal laboratory investigation. – Status control: implementing status labels to clearly identify workflow status such as issues, returns, rejects and reworks of components to prevent mix ups. No, this will be a violation of good laboratory practice.

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Documentation Packaging Process Improvement Pharmaceutical Manufacturing 52

GMPSOP

JULY 31, 2023

Alarm and safety test: Acceptance Criteria: The autoclave’s alarms should activate and safety interlocks should function correctly when triggered by predefined events or conditions. 90% to 110% of the label claim). 5% of the average force).

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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. 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 Pharmaceutical Manufacturing Labelling 52

FDA Law Blog: Biosimilars

JANUARY 22, 2025

Wasserstein & Dara Katcher Levy Who among us, upon reading FDAs draft guidance on the distribution of off label information and their coining of the acronym SIUU (standing for Scientific Information on Unapproved Uses ) did not automatically think of Phil Collins classic song Sussudio ? Other than anyone under 50, that is.

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Labelling Communication 59

PharmaShots

APRIL 3, 2023

events/100 patient-yrs.) The results also showed a reduction in risk of hospitalization for any cause with 14% relative risk reduction (24.8

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Biosimilars Diabetes Compounding Hospitals 40

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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RX Note

FEBRUARY 23, 2023

G6PD Deficiency - Explaining G6PD Deficiency Ramadan - Medications during Ramadan fasting Adverse Drug Reactions Adverse Drug Reactions - All adverse reactions are adverse drug event Pharmacovigilance - To detect unreported ADRs Drug Allergy - Management vary based on the signs and symptoms Medicine-induced Discolouration - Red?

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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. This can be used in the event of food poisoning, accidental ingestion of a food you’re sensitive to, or for binding mycotoxins and other pathogenic gut infections. It helps eliminate unwanted microbes and toxins.

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FDA Law Blog: Biosimilars

JULY 9, 2024

This could be based on differential pharmacokinetics (“PK”) or pharmacodynamics (“PD”), possible differences in susceptibility to specific adverse events of concern, or due to differential presentation of the disease or condition. If FDA determines that a waiver will be issued, it may consider public communications about the decision.

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Drug Development Communication Documentation Labelling 59