Pharmaceutical Technology

APRIL 17, 2023

On 14 April 2023, experts from the US Food and Drug Administration’s (FDA) Advisory Committee (AdCom) voted largely in favour of the potential approval of Otsuka’ s and Lundbeck Pharmaceuticals’ Rexulti for the treatment of agitation associated with Alzheimer’s dementia (AAD). Rexulti is an atypical antipsychotic.

Medical Schools 96

Medical Schools Labelling Communication 96

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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Communication Labelling 86

FDA Law Blog: Biosimilars

APRIL 25, 2023

This provision became effective as of March 29, 2023. It will become part of the “refuse to accept” (RTA) checklist on October 1, 2023. The technological characteristics in this context may cover a wide range of device functions, for instance, monitoring features, stimulation parameters, and communications with healthcare providers.

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Documentation Labelling Communication 105

Big Molecule Watch

JANUARY 10, 2025

The reductions in price ranged from 38 to 79 percent of the 2023 listed prices for the drugs. pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. These new prices will take effect starting January 1, 2026.

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Biosimilars Drug Pricing Labelling Communication 45

Pharmaceutical Technology

MAY 3, 2023

In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201. With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. Tenaya is also running two supplementary non-interventional studies for the drug.

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Mayo Clinic Labelling Communication 97

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]. cited 2023 July 4]. 2023 Jun;38(6):1733-1751. Pediatr Nephrol.

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Labelling Communication 177

FDA Law Blog: Biosimilars

JUNE 27, 2023

On June 12, 2023, FDA issued a public notice to solicit comments on the information collection related to the voluntary submission of allegations of regulatory misconduct to CDRH. Any comments to the public notice must be submitted by August 11, 2023. There are drawbacks to the current communication channels: 1.)

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Documentation Labelling Communication 59

pharmaphorum

AUGUST 11, 2021

On Axsome’s second-quarter results call, chief executive Herriot Tabuteau said that the FDA letter received on 30 July indicated that the problems with the filing “preclude discussion of labelling and post-marketing requirements,” adding that the company has been in communication with the regulator to try to learn more.

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Labelling Communication 52

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. But a Warning Letter?

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Labelling Controlled Substances Communication 52

Pharmaceutical Technology

JANUARY 15, 2023

In the first 2023 edition of the CMO Moves monthly series , Pharmaceutical Technology explores recent news stories on regulatory and reimbursement decisions in different countries, and the companies linked to their success and failures. FDA expands approval labels. Please check your email to download the Report.

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Labelling Packaging Communication Diabetes 52

Pharmaceutical Technology

JANUARY 6, 2023

In a press release, the company said a generic launch would damage sales in FY 2023 by $300,000. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. In September, Novartis announced its plans to petition the US Supreme Court to reverse the aforementioned decision.

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Documentation Hospitals Dosage Drug Pricing 97

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.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

PharmaState Academy

DECEMBER 12, 2023

Summary for Masterclass: Applicable Laws Regarding Promotional Materials in Pharma Marketing held on 7th Dec 2023. Dr. Ashok, a global health and pharmaceutical industry leader, then led a Q&A session where they shared their views on the regulatory framework for medico marketing communications.

Communication 52

Communication Hospitals Labelling 52

RX Note

MARCH 23, 2023

Today, stability information can be obtained from manufacturer’s labelling information (such as in the package insert), the USP compounding monographs, or peer-reviewed articles and references , such as articles in American Journal of Health-System Pharmacy, the International Journal of Pharmaceutical Compounding.

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Compounding Sterile Compounds Packaging Labelling 52

Putting Patients First Blog

APRIL 7, 2025

Furthermore, FDA guidance should include requirements for clear labeling and disclosure of any remaining performance limitations or biases, ensuring clinicians and patients are aware of potential constraints in real-world contexts.

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Documentation Communication Pharmaceutical Manufacturing Labelling 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., josh.levin@usp.org Thu, 08/03/2023 - 15:43 Supply Chain

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Packaging Compounding Pharmacies Pharmaceutical Manufacturing Documentation 52

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

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). Manufacturers should create user-friendly instructions for use that facilitate patient understanding of potential risks over the expected lifespan of the implant.

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Documentation Labelling Communication 45

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.

Hospitals 52

Hospitals Labelling Communication Pharmaceutical Companies 52

FDA Law Blog: Biosimilars

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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Packaging Documentation Labelling Communication 59

Pharmaceutical Technology

MARCH 20, 2023

According to GlobalData figures, the worldwide percentage of clinical trials started and completed in Africa between 9 December 2012 and 8 March 2023 was 2.2%. Rates of non-communicable diseases such as hypertension, cardiovascular disease, chronic respiratory diseases, diabetes, and cancers are also considered high throughout Africa.

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Communication Diabetes Labelling 52

Pharmaceutical Technology

MAY 23, 2023

In its Q1 report , Centessa stated plans to present more data from part five of the open-label expansion of the Phase IIa study, subject to completion, at an undisclosed scientific meeting in 2023. The multicentre, first-in-human study also investigated the the drug’s actions in the body and how drug levels vary in the blood over time.

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Labelling Communication Drug Development 59

ID Stewardship

JUNE 6, 2023

BCPS, BCIDP Article Posted 7 June 2023 With the exception of the questions in bold, this entire text was written by ChatGPT. Streamlined Prescription Filling : AI systems can automate prescription filling processes by extracting relevant information from electronic prescriptions, verifying insurance coverage, and generating labels.

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Insurance Coverage and Processing Prescription Filling Hospitals Medication Dispensing 52

Putting Patients First Blog

JULY 10, 2023

NHC Comments on PFDD: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making (PDF) July 5, 2023 Robert M. Communication with the FDA We appreciate that the FDA has emphasized the need for sponsors and patients to interact with the Agency early and often when utilizing these guidances. Califf M.D.,

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Communication Drug Development Packaging Labelling 40

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: June 3, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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Documentation Packaging Communication Customer Service 52

GMPSOP

MAY 26, 2023

Six steps process to implement change control management Pharmaceuticals quality assurance & validation procedures GMPSOP Six steps process to implement change control management Last modified: May 28, 2023 Table of Contents “It is not the strongest of the species that survive, nor the most intelligent, but the one most responsive to change”.

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Documentation Packaging Communication Customer Service 52

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. Comprehensive Transparency: AI applications should be fully disclosed, explainable, and accessible to patients and providers in layperson terms.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

GMPSOP

JULY 23, 2023

Challenges include inadequate preparation, poor documentation, insufficient resource allocation, and lack of clear communication. The other two tests are operational (OQ) and performance qualifications (PQ) which are done successively after the IQ. Manufacturing Machinery: Such as tablet presses, filling machines, and sterilization equipment.

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Documentation Method Validation Packaging Labelling 52

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

Pharmaceutical Technology

MARCH 21, 2023

A few weeks later, the EC extended the approval label of AstraZeneca’s Forxiga (dapagliflozin) to include the treatment of symptomatic hearth failure. FDA and EMA decisions In January, the European Commission (EC) approved Roche’s Xofluza (baloxavir marboxil) to prevent and treat influenza in children ages one year and older.

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Packaging Vaccines Labelling Communication 59

Pharmaceutical Technology

MAY 25, 2023

The ongoing Phase 1/2a ( NCT04725331 ) study is a multicentre, open label, dose-escalation trial evaluating BT-001 as a single agent and in combination with the anti-PD-1 treatment, Keytruda. The first patient in this combination cohort is expected to be enrolled in H2 2023. Keytruda for the trial is provided by MSD (Merck & Co).

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Labelling Communication Vaccines 52

Pharmaceutical Technology

JANUARY 5, 2023

The pharmaceutical industry has long been labelled as a recession-proof—stable demand for medicines and new treatment options acts as a protective barrier. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Please check your email to download the Report.

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Drug Pricing Vaccines Labelling Communication 69

epicur

JANUARY 4, 2023

The product is what it says it is on the label, it’s 100% manufactured and we’re giving them a product that they can use for office administration and dispensing so they can start patient care immediately. Where will you be kicking off 2023? When you’re working with a new veterinary practice how do you explain that value to them?

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Compounding Compounding Pharmacies Hospitals Customer Service 52

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 101

Health and Personal Care Stores Immunity Immunization Compounding 101

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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Health and Personal Care Stores Immunity Immunization Grocery Stores 105

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. Accessed September 18, 2023. Accessed September 9, 2023. Accessed September 18, 2023. She was fierce, fun, dedicated, and brilliant. January 2017. link] same-in-depth. [10]

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Health and Personal Care Stores Immunity Immunization Dosage 98

GMPSOP

JULY 14, 2023

They should never be topped up, used, or stored without labels and expiry dates. via visual inspection or by communication with the responsible personnel). You must display the cleanliness status of each equipment unit or item, by using labels and/or signs or a centralized paper-based or validated electronic system.

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Documentation Labelling Pharmaceutical Manufacturing Packaging 52