article thumbnail

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. This record-keeping includes detailed documentation of the product’s history and movement through the supply chain. It also enables precise tracking and tracing of each drug package.

article thumbnail

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

The FDA Law Blog

FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. By Day 15 FDA conducts Acceptance Review. By Day 60 FDA conducts Substantive Review.

FDA 75
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

New IFPMA and EFPIA guidance on use of social media by the pharmaceutical industry

pharmaphorum

The overarching principle set out in Codes of Practice, and in particular the Principles for the use of digital channels in the EFPIA Code , is that the legislation and Codes of Practice apply equally to communications by companies on social media and digital channels.

article thumbnail

Bridging the healthcare digital divide: a gradual approach to adopting ePI

European Pharmaceutical Review

These standardised documents provide meticulously curated and scientifically approved information. 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 percent as EU average with some Member States as high as 25 percent).

article thumbnail

9 ways pharmacy technician roles are changing

The Checkup by Singlecare

This includes counting, measuring, and packaging medications, as well as labeling and organizing them for distribution. They work closely with pharmacists to ensure that medications are prepared and dispensed accurately and safely,” he says.

article thumbnail

Assumptions to evidence: How NINR project is solidifying UK’s remote trial know how

pharmaphorum

Through a series of workshops and surveys, which collected the views of research professionals, patients and carers, the group has developed a new guidance document. But how do we package that up?” A practical consensus. Everything has moved so quickly.

article thumbnail

Welcome to SRP-RMT – Standardization Comes to Regenerative Medicine Therapies?

The FDA Law Blog

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

FDA 59