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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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.

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Communication Hospitals Labelling 52

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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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

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

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.

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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

PharmaShots

APRIL 3, 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Date - Jan 04, 2023 Product – N/A The acquisition is completed from a shareholder group led by Nordic Capital, in an all-cash transaction valued at $2.8B per ADS up front & CVR of ~$2.50

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Biosimilars Diabetes Compounding Hospitals 40

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). Going back and looking through 2020 at the products involved in letters, there have been a total of 17 letters (involving 19 different communications vehicles).

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Labelling Communication 82

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

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

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

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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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

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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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

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

European Pharmaceutical Review

SEPTEMBER 22, 2023

Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. 2023 AD/PD Conference. Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Brain Communications.2022;4(1). References Hendrix S. Wang CY, et al.

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Immunity Immunization Vaccines Communication 77

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 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.

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Health and Personal Care Stores Immunity Immunization Compounding 66

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 82

Pharmaceutical Technology

DECEMBER 4, 2022

Humira is indicated for 10 adult and pediatric conditions, including Crohn’s disease, rheumatoid arthritis, and ulcerative colitis, as per its label. Indeed, Amgen’s biosimilar was approved in September 2016, but the company was not able to launch it until January 2023 in the US. Temporary first-to-market advantage.

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Biosimilars Labelling Communication Hospitals 104

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 Diabetes 59

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

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

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 Diabetes Communication 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

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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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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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. Accessed January 20, 2023.

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Dosage Documentation Diabetes Labelling 83

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 You can learn more about adrenal dysfunction, as well as how to address and treat it through an at-home protocol, in my new book, Adrenal Transformation Protocol , which is coming out in spring 2023!

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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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