FDA Law Blog: Biosimilars

MARCH 8, 2023

By Véronique Li, Senior Medical Device Regulation Expert — On March 17, 2023, enhancements to FDA’s electronic Medical Device Reporting (eMDR) system will go live. Test deployment for the changes listed above were deployed to eMDR on August 19, 2022 and will be deployed to production on March 17, 2023.

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European Pharmaceutical Review

JANUARY 25, 2024

7 Access to digital communications also remains a challenge in some Member States especially for those groups at risk of poverty and social exclusion (7.6 References European Commission, (26 April 2023). Euractiv (6 October 2023). European Commission (26 April 2023). Article 63 Euractiv (26 September 2023).

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Packaging Documentation Communication Pharmaceutical Companies 82

Pharma Marketing Network

MARCH 25, 2023

All communications, both internal and external, should reflect the brand’s values and personality. This includes everything from the company’s website and social media presence to packaging and advertising. This can include creating a brand mission statement, defining brand values, and developing a brand personality.

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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

Express Pharma

DECEMBER 11, 2023

The latest in this series, Chandigarh Pharma Summit 2023 was successfully hosted by Express Pharma recently. In this article, we delve into the highlights of the Chandigarh Pharma Summit 2023, and showcase the key takeaways and insights from the presentations and discussions at the event.

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Packaging Communication Documentation 92

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

National Association of Boards of Pharmacy

JUNE 26, 2023

As the final milestone for DSCSA quickly approaches on November 27, 2023, our goal is to make sure members of the drug supply chain have the connections and tools needed to ensure compliance. Review your systems and processes for DSCSA required investigations, including package-level verification.

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Community Pharmacies Packaging Communication 52

epicur

AUGUST 8, 2023

It was a busy first six months of 2023 for veterinary professionals and practices, and the rest of the year isn’t likely to slow down. Impending USP Guidelines on Beyond-Use Dates Coming in late 2023, new USP guidelines will limit Beyond-Use Dates (BUDs) on drugs from 503A compounding pharmacies. It often starts with communication.

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Compounding Documentation Compounding Pharmacies Packaging 52

Integra X Files

DECEMBER 19, 2022

These plans can change every year, so it’s wise for pharmacies to be aware of which Part D 2023 plans will no longer be serving dual-eligibles so they can prepare for changes. Keep communicating with your facility customers to understand how enrollment is changing.

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Nursing Homes Documentation Dosage Packaging 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

Quality Matters

MAY 23, 2023

They include the potential for substandard packaging and shipment, falsification of product information and markings, detection of undeclared chemicals, high variability of quality across samples, and payment for orders being subject to fraud. kristine.gates… Tue, 05/23/2023 - 10:25 Supply Chain

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Online Pharmacies Controlled Substances Packaging Communication 52

GMPSOP

JULY 23, 2023

Add the objective of the installation qualification protocol Write the objective of the protocol defining the installation qualification (IQ) and operational qualification (OQ) requirements and acceptance criteria for the equipment with location i.e., packaging or manufacturing, and the facility.

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Documentation Method Validation Packaging Labelling 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

JUNE 16, 2023

Importance of acceptance criteria in analytical method transfer Pharmaceuticals quality assurance & validation procedures GMPSOP Importance of acceptance criteria in analytical method transfer Last modified: June 17, 2023 Table of Contents What is analytical method transfer? QA maintains communication between the laboratories.

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Documentation Dosage Communication Method Validation 52

GMPSOP

JULY 14, 2023

In other areas, such as in secondary packaging or in material storage areas, the product isn’t exposed to the environment, so there is a lower risk of contamination. via visual inspection or by communication with the responsible personnel). in the next batch or campaign record). – Has been cleaned. – Is visibly clean.

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Documentation Labelling Pharmaceutical Manufacturing Packaging 52

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

It is vital that communication, both for beneficiaries and for health care providers and pharmacists, adhere to these principles. Lastly, the NHC stresses the importance of continuous monitoring and evaluation of the outreach, education, and communication strategies to identify areas for improvement.

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Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

ID Stewardship

NOVEMBER 29, 2023

BCPS, BCIDP Article Posted 1 December 2023 Podcasting has emerged as an incredible way to reach a global audience and discuss scientific information. Not being afraid to communicate with people has been important to my success. Interviewee: Luis Plaza Interviewer: Timothy P. Gauthier, Pharm.D.,

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Hospitals Packaging Communication 88

The Thyroid Pharmacist

OCTOBER 27, 2023

Follow package instructions. These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Follow package directions for each supplement. The herb itself can be poisonous if ingested. They’re great for injuries, overuse, or soreness from workouts.

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Health and Personal Care Stores Immunity Immunization Compounding 66

Pharmaceutical Technology

MARCH 21, 2023

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Packaging Vaccines Labelling Diabetes 59

Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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Packaging Compounding Pharmaceutical Companies Pharmaceutical Companies 52

Pharmaceutical Technology

FEBRUARY 9, 2023

Container Closure Integrity Testing (CCIT) is used to evaluate the ability of a pharmaceutical’s primary packaging to protect the sterility of its contents. On a regular basis, pharmaceutical manufacturers are performing CCIT during commercial production to ensure that packaging processes are operating as they should.

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Packaging Pharmaceutical Manufacturing Communication Pharmaceutical Companies 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. Please check your email to download the Report.

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Labelling Packaging Diabetes Communication 52

Pharmaceutical Technology

MARCH 22, 2023

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

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Pharmaceutical Manufacturing Packaging Diabetes Communication 105

Pharmaceutical Technology

APRIL 21, 2023

On March 29, 2023, the US Food and Drug Administration (FDA) granted approval that made Narcan the opioid treatment drug to be sold without a prescription. The overdose US death rate that has seen a 250% increase from 1999 to 2019. Please check your email to download the Report.

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