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September 2023 Newsletter

Safe Biologics

6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. However, S.6 This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation.

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October 2023 Newsletter

Safe Biologics

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert.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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Dhairy Sharma, Technical Sales, CILICANT | Indore Pharma Summit 2023

Express Pharma

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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Transdermal and Microneedle Drug Delivery 2023

pharmaphorum

The 2023 Transdermal and Microneedle Drug Delivery Conference will explore real world applications of microneedles in drug delivery and strategies for advanced and user-centric device design. Microneedle Device Developers. Transdermal Delivery Developers. Microarray Patch Developers. Secondary Packagers.

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STAT+: ‘Like playing the lottery’: A mixed picture for laid-off life sciences workers in Massachusetts

STAT

The state’s biotech scene   exploded in the mid-2010s and early in the pandemic as exuberant investors disregarded the high failure rate in drug development and bet on buzzy technologies such as gene editing and messenger RNA vaccines. But the   drumbeat of layoffs in 2022   has only grown louder this year.

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Develop and execute a winning drug launch strategy with an experienced contract packager

Pharmaceutical Technology

Navigating the complexities of pharma and biotech packaging services can be difficult. With the growing number of complex therapies that require specialized packaging and handling requirements, selecting the right contract packaging organization (CPO) involves evaluating what services and additional benefits they can bring to your business.

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Five potential EU regulatory changes impacting the life sciences industry in 2023

European Pharmaceutical Review

A wave of important legislative changes is anticipated in the EU in 2023 making this year one of the biggest for the EU regulatory landscape governing the life sciences industry in recent times. As a key priority action under the ACT EU initiative, EU regulators plan to establish a multi-stakeholder platform (MSP) in 2023.

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