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STAT+: How the first over-the-counter birth control pill in the U.S. got its ‘unapologetic’ design

STAT

It’s not every day that a marketing team is tasked with designing the branding and packaging of the first over-the-counter birth control pill to be sold in the U.S.

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Shanghai ISPE Pharmaceutical Information Company holds 2022 China Pharmaceutical Supply Chain Summit

ISPE

Thanks to the clinical supply chain service companies' years of industry development and operation, there are new developments in global supply chain layout, ultra-low temperature storage and distribution management breakthroughs, and growing packaging and labeling capabilities. By Li Jie of ClinsChain

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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

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Navigating Regulatory Challenges in Pharma Marketing: Best Practices

Pharma Marketing Network

Navigating these regulatory challenges is essential to ensure compliance, maintain trust, and effectively communicate the benefits and risks of pharmaceutical products. Stay Informed and Updated Regulations in the pharmaceutical industry are constantly evolving. Keep thorough records of approvals for future reference.

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FDA issues draft guidance on alternative tools for facility assessments

European Pharmaceutical Review

Assessing drug manufacturing facilities using alternative tools The FDA stated in the guidance that all manufacturing, packaging, and control sites for drug substance and drug product facilities are expected to be ready for inspection at the time of application submission.

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DSCSA Compliance for Independent Pharmacies

DiversifyRx

This tracking involves the use of unique product identifiers, such as serial numbers and barcodes, on drug packaging to track their movement. Serialization Serialization is the process of assigning a unique identifier, typically a serial number, to each prescription drug package. The DSCSA aims to streamline this recall process.

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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach

The FDA Law Blog

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

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