The FDA Law Blog

JULY 10, 2023

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.

FDA 75

FDA Documentation Packaging Communication 75

DiversifyRx

NOVEMBER 24, 2023

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.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

The FDA Law Blog

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.” Existing published VCS may be identified internally by FDA or externally by stakeholders.

FDA 59

FDA Packaging Documentation Labelling 59

ISPE

MAY 11, 2023

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. 3 , 4 RAMI integrates all assets, including physical items, software, administrative shell, documents, and personnel. Methodology to Define a Pharma 4.0™ It supports the analysis of Industry 4.0 to Industry 4.0

Packaging 52

Packaging Documentation Communication Data Entry 52

ISPE

SEPTEMBER 11, 2023

4 , 5 Additionally, reducing shipping limitations—such as packaging, storage, and transportation durations—helps speed up patient access in certain instances while ensuring there is no negative impact to the product’s critical quality attributes (CQAs). Nature Communications 12, no. Biotechnology Progress 36, no. 3 (2020):e2970.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

SEPTEMBER 11, 2023

The setpoint for “proper” air velocity in cleanroom systems is documented in standards and regulations as 0.45 9 In 2015, the FDA published a guidance manual 10 that provided questions for inspections, including: Is the air flow in critical areas unidirectional when delivered to the point of use? m/s up to 0.54 At what velocity?

Documentation 52

Documentation FDA Packaging Communication 52