FDA Law Blog: Biosimilars

DECEMBER 6, 2024

The draft guidance recommends that no more than 15 questions are included in the briefing package. CBER will not commit to reviewing packages greater than 250 pages. Such stopping rules should specify the number of adverse events, as well as the nature/severity of these events, which would trigger such a determination.

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Documentation Packaging Clinical Pharmacology Drug Development 59

pharmaphorum

MAY 4, 2022

Our expert industry thought leaders will present case studies and updates to the industry’s approach to injectable delivery for novel drug products. Furthermore, our speakers will be assessing the key considerations for primary packaging and CMC approaches to injectable device development. Primary Packaging material designers.

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European Pharmaceutical Review

SEPTEMBER 15, 2023

EPR are attending the event – let us know so our team can organise an interview with you or your company, or provide more information on opportunities such as sponsorship. Award winners will be revealed at a networking reception on the first day of CPHI Barcelona 2023, which is running from 24-26 October.

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Packaging Drug Development 119

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S. However, S.6

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Express Pharma

SEPTEMBER 20, 2023

In this video: Dhairy Sharma, Technical Sales, CILICANT Topic: Role of active packaging in drug development Key Takeaway: ACCUFLIP from Cilicant regulates Equilibrium Relative Humidity (ERH) within a specific range in order to protect medications from over-desiccation.

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Packaging Drug Development 52

Express Pharma

JUNE 16, 2023

In this video: Dhairy Sharma, Technical Sales, CILICANT Topic: Role of active packaging in drug development Key Takeaway: ACCUFLIP from Cilicant has been designed to regulate Equilibrium Relative Humidity (ERH) within a specific range in order to protect medications from over-desiccation.

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Packaging Drug Development 52

PharmaState Academy

MARCH 7, 2024

a) Enhancing Packaging Aesthetics b) Monitoring Process Compliance c) Maximizing Production Speed d) Optimizing Sales Strategies Analytics monitors process compliance, ensuring adherence to regulatory guidelines and maintaining product quality standards.

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Packaging Drug Development Pharmaceutical Manufacturing 64

Pharmaceutical Technology

JUNE 12, 2025

Outsourcing is now a fundamental part of drug development and distribution. Delays at the border due to customs, which can imperil the integrity of these life-saving drugs, are to be avoided at all costs.

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Health and Personal Care Stores Communication Drug Development Packaging 52

pharmaphorum

DECEMBER 9, 2021

After making her way from early-stage drug development research to her current role, Heather got straight to work on creating sustainable collaborations that made life better for people and their families. “I I am fascinated by the breadth of my role, which encompasses self-care products, skin health, sustainability and much more.

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Packaging Drug Development 105

European Pharmaceutical Review

JUNE 24, 2022

The review was impacted by Brexit and the COVID-19 pandemic, which compounded existing issues surrounding high drug pricing and patient access that had been brewing since 2016 and highlighted several shortcomings in the EU’s pharmaceutical system. pocket expenses account for only seven percent of the overall cost of developing drugs.

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Compounding Drug Development Drug Pricing Dosage 105

European Pharmaceutical Review

FEBRUARY 7, 2023

The platform itself is scheduled to kick off in the second quarter of 2023 followed by stakeholder events during the third quarter. Halting Europe’s essential medicines manufacturing exodus As a result of the expiry of the first transitional period and MSP initiative, 2023 is likely to be a revealing year for clinical trials in the EU.

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Packaging Drug Development 117

pharmaphorum

AUGUST 12, 2022

Embracing continuous manufacturing should be part of a broader push to make American and European drug production the most advanced and innovative in the world. Whether it’s a public health emergency, international conflict, or severe weather event, the next shock is coming.

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Packaging Drug Development 59

Pharmaceutical Technology

NOVEMBER 30, 2022

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT.

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Pharmaceutical Technology

NOVEMBER 28, 2022

We source as much of the materials as we possibly can locally, even packaging,” he notes. When we need new packaging, it is really simple to get and it is quick. To learn more about the development and partnership opportunities for businesses within Scotland’s health sector, download the document on this page. Free Whitepaper.

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Hospitals Packaging Medical Schools Documentation 52

PharmaShots

FEBRUARY 27, 2023

The theme of the event was Innovation, Advanced Technology, Current Challenges & Opportunities in Pharma & Healthcare Industry under which a series of presentation sessions and panel discussions were held related to pharma trends, APIs, policy reforms, AI, metaverse, current regulatory trends and the direction of pharma and drug discovery.

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PharmaTech

JUNE 6, 2025

These may either be specific to the production process itself (such as pyroglutamination of the N-terminus as is frequently seen in monoclonal antibodies (mAbs) or may be the result of purification processes (such as amino acid oxidation or deamidation events) and may indicate that process change is required.

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Dosage Drug Development Documentation Biosimilars 52

PharmaTech

JUNE 11, 2025

Hesperos, Psilera Agree to Accelerate Organ-on-a-Chip Treatment for Frontotemporal Dementia Patrick Lavery June 9th 2025 Article The partnership leverages the Hesperos organ-on-a-chip platform in the preclinical development of Psilera’s lead compound targeting the progressive neurological disorder for which treatment options are few.

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pharmaphorum

FEBRUARY 28, 2022

As part of SMi’s leading series of drug delivery device conferences, the 2022 event will provide insights into the rapidly accelerating market of combination product development with industry, device developer and regulatory perspectives. As one of our most sought-after events, this conference is not to be missed.

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Packaging Drug Development Vaccines 52

pharmaphorum

JANUARY 18, 2022

Primary Packaging material designers. Secondary packagers. Smart device developers. Training device developers. Drug developers. Registrations can be made on the event website at: www.pfsamericas.com/. . Medical Device Engineers. Device-safety solution providers. EARLY-BIRD RATES: .

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Packaging Documentation Drug Development Vaccines 52

PharmaTech

JUNE 6, 2025

Image Credit: © nordroden - stock.adobe.com TurboFil Packaging Solutions is introducing its newest piece of equipment, called the MediFil Cart (1). Automatic machine for filling ampoules and vials. Modern pharmaceutical equipment.

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Dosage Packaging Drug Development Vaccines 52

pharmaphorum

OCTOBER 12, 2022

Microarray Patch Developers. Primary Packaging Material Designers. Secondary Packagers. Smart Device Developers. Training Device Developers. Drug Developers. Transdermal Drug Product Developers. The post Transdermal and Microneedle Drug Delivery 2023 appeared first on.

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Packaging Drug Development Vaccines 40

PharmaTech

JUNE 12, 2025

By combining assets, both companies aim to streamline mRNA drug development pipelines and manufacturing workflows, potentially reducing timelines for delivering clinical-stage therapies to patients. billion (1). billion (1). The integrated platform will be positioned to support mRNA applications from discovery to commercialization.

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Dosage Drug Development Vaccines Packaging 52

PharmaTech

JUNE 10, 2025

As we observed in an industry analysis we performed comprising 1200 clinical programs, only a minority of companies currently optimize their development for commercial success,” Baumann says.

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Dosage Drug Development Vaccines Compounding 52

PharmaTech

JUNE 12, 2025

The warnings encompassed various forms of lack of compliance in the agency’s view, including product mislabeling, false or misleading claims on packaging, and shortfalls in current good manufacturing practice (CGMP) standards found during laboratory inspections.

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Dosage Drug Development Labelling Compounding 59

PharmaTech

JUNE 11, 2025

Linking Neuroscience to Therapeutic Development Key Takeaways ·European biotech startup Elkedonia secures €11.25M (US$12.9M) in seed funding, integrating Sorbonne University research with Argobio’s drug development expertise.

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Dosage Drug Development Packaging Vaccines 52

Express Pharma

APRIL 12, 2025

Advanced packaging solutions help ensure compliance and usability The post Panel Discussion: Aligning packaging strategies with R&D appeared first on Express Pharma.

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