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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FDA Law Blog: Biosimilars

AUGUST 11, 2024

Presenting only information about the benefits or efficacy of a prescription drug, like AUVI-Q, without any risk information is considered a false or misleading presentation under the Federal Food, Drug and Cosmetic Act (FDCA), and is considered misbranding of the product.

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Labelling Communication 57

Eye on FDA

AUGUST 22, 2023

The Untitled Letter posted this week involved an oral birth control pill which has a specific of contraindications contained in the label as well as a list of warnings and precautions and of the most common adverse events. The communications vehicle in question was a social media sponsored posting. Pharma communicators take note.

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Eye on FDA

JANUARY 22, 2024

The communications vehicle that was the subject of the letter was a Direct-to-Consumer (DTC) television advertisement that had been submitted for agency review. There is a larger trend that may be in play – not the communications vehicle, but regarding the type of violation cited by OPDP.

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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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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

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Labelling Packaging Communication Pharmaceutical Companies 52

Eye on FDA

JUNE 14, 2023

The label for the medicine includes a boxed warning regarding potential issues related to complications for the liver (toxicity) and heart (QT prolongation). The agency acknowledged that full risk information was presented on the webpage, but felt that did not mitigate the overall characterization that minimized risk.

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Pharma Marketing Network

AUGUST 9, 2023

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Develop Clear and Balanced Messaging Effective communication is at the heart of pharmaceutical marketing. Keep thorough records of approvals for future reference.

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Labelling Packaging Communication Pharmaceutical Companies 40

Pharmaceutical Technology

APRIL 17, 2023

However, the treatment’s label features a black box warning that includes increased mortality in elderly patients with dementia-related psychosis treated with antipsychotic drugs. He added that there is also a need for FDA-approved products that communicate efficacy and safety on their labels.

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Medical Schools Labelling Communication 96

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] report certain device malfunctions, and.

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Labelling Communication Documentation 62

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. OPDP first took issue with a headline and graph presented on page 7 of the 12-page brochure. What does this mean ?

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Labelling Controlled Substances Communication 52

European Pharmaceutical Review

JANUARY 23, 2023

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. In addition, MSSG supports temporary national measures such as unit dose dispensing and compounding.

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European Pharmaceutical Review

NOVEMBER 24, 2022

Tackling pharmaceutical counterfeiting continues, therefore, to be a clear and present priority for manufacturers, healthcare authorities and law enforcement. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

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Packaging Labelling Documentation Dosage 111

Eye on FDA

JULY 7, 2020

This year the unprecedented circumstances presented by the COVID-19 pandemic make it particularly interesting this year. The communications vehicle that incurred the violation was a sponsored link that appeared on Google. A good place to start is with regulatory enforcement of the Office of Prescription Drug Promotion (#OPDP).

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Communication Documentation Labelling Pharmaceutical Companies 52

pharmaphorum

SEPTEMBER 29, 2022

Effective communication is vital for addressing […] barriers, and language is one of the key tools we use to communicate. Despite this, non-inclusive words, phrases, and labels are often used in scientific publications and clinical trial protocols. Barriers to health. Making change.

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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 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

pharmaphorum

MARCH 30, 2021

Pharma is moving to a new era of radically new therapies, presenting unexpected and difficult challenges. Such interventions take the need for robust value claims to a completely different level, with important implications for the evidence companies need to collect, and how they collect and communicate it.

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GMPSOP

AUGUST 11, 2024

Documentation : Keeping detailed records of orders, specifications, manufacturing processes, packaging, and labeling to ensure traceability and compliance. Packaging and labeling operations for investigational products are often complex and must meet specific requirements to ensure the integrity of clinical trials. Subscribe 6.

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Packaging Documentation Labelling Dosage 52

Viseven

JULY 25, 2024

billion for the illegal marketing of four of its off-label drugs, which became one of the biggest fraud settlements in the healthcare industry. This includes verifying the evidence presented, the research results, and even the factual information. For example, Pfizer was fined $2.3

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FADIC

SEPTEMBER 12, 2023

Design & Implementation: Creating and implementing strategies to improve safety, which can range from better labeling practices to the use of advanced technology. Why Every Pharmacist Should Engage in Medication Safety Project Comprehensive Support covers everything from the initial brainstorm to the final presentation.

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Patient Counseling Medication Delivery Labelling Communication 52

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia. Question 36: Dossier Submission.

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FDA Law Blog: Biosimilars

JULY 10, 2023

We will then present an effective strategy to address FDA’s AI request in a timely manner. However, the strategy of addressing the AI request presented in the next section of this blog post applies to all three types of 510(k)s. Table 1 below shows the 510(k) submission process based on the MDUFA III Performance Goals.

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Documentation Packaging Communication Labelling 75

FADIC

JULY 14, 2024

OTC drugs come in various forms, including tablets, capsules, creams, and liquids, and are generally labeled with clear instructions on proper usage and dosage. The FDA’s website provides a wealth of information on OTC drugs, including product labels, warnings, and recalls.

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Adverse Reactions Dosage Mayo Clinic Medical Schools 105

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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FDA Law Blog: Biosimilars

JUNE 27, 2023

We have seen companies submit screenshots of social media sites making misleading promotional claims, pictures of violative product labeling, and evidence of damaged or uncalibrated manufacturing equipment. FDA could present this information in a Frequently Asked Questions (FAQ) section, like it uses on other webpages describing its programs.

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pharmaphorum

OCTOBER 4, 2022

4) intended for the purpose of enabling such HCPs to independently review the basis for such recommendations that such software presents, so that it is not the intent that such HCPs rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient (Criterion 4). Criterion 3.

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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]. Identify the medullary pyramids, calyces, renal cortex, and renal pelvis (Figure 4).

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PharmaState Academy

SEPTEMBER 29, 2023

A very strong leader with excellence in communication skills may also cause this to happen. He may present his case so forcefully, that rather than be conspicuously different or cause difficulties; people decide to just go along with it. The `Abilene Paradox’ plagues Pharma India too, severely.

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Labelling Communication 52

pharmaphorum

MARCH 15, 2022

Moreover, from a global perspective, doctors may no longer have to endure Fear of Missing Out (FOMO) from learning of important medical advances presented at international meetings. Presentation skills. The ‘hybrid’ label is confusing. Jeff Bateman, head strategic communications [link]. TV studio management.

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Labelling Vaccines Communication 105

European Pharmaceutical Review

SEPTEMBER 22, 2023

AC Immune’s vaccine candidate, ACI‑24.060, is a liposomal active immunotherapy, presenting the Abeta 1-15 peptide in a unique, conformationally‑restricted manner such that the induced antibody response shows very high specificity towards the pathological Abeta species such as oligomers and pyroglutamate Abeta. Brain Communications.2022;4(1).

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Immunity Immunization Vaccines Communication 97

pharmaphorum

NOVEMBER 16, 2020

Effective, impactful brand communications that deliver tangible results. For example, that the active voice is more powerful than the passive; that something labelled ‘tender chicken’ is more desirable than just ‘chicken’. Present it. Our creative philosophy has always been simple. To produce works that works. Craft matters.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

To request an FEI Number, laboratories will need to provide a long list of identifying information to FDA via email ( feiportal@fda.hhs.gov ) ( see slide 23 of the FDA’s presentation for the complete list). Corrections and Removals Under 21 CFR Part 806, manufacturers generally need to communicate corrections and removals (i.e.,

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Labelling Communication 62

RX Note

JUNE 2, 2024

However, the business world presents a different reality. 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. Collaboration is key.

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GMPSOP

MARCH 4, 2023

According to FDA Guidance for Industry – Q9 Quality Risk Management , “Quality risk management is a systematic process for the assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle. How to communicate risk? What is quality risk management in pharmaceutical?

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GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed for effectiveness, and communicated to a larger audience. – Assessment of packaging and labeling components.

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Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Change control management is a systematic process by which a change to facilities, products, systems, or processes is proposed, assessed by a committee (technical and operational impacts), approved, implement, reviewed effectiveness, and communicated to a larger audience. – Assessment of packaging and labeling components.

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Documentation Packaging Communication Customer Service 52