Drugs

Study Data Technical Conformance Guidance

FDA has released a final guidance entitled “Study Data Technical Conformance Guide - Technical Specifications Document” that provides specifications, recommendations, and general considerations on how to submit standardized study data using FDA-supported data standards located in the FDA Data Standards Catalog. The document supplements the guidance “Providing Regulatory Submissions in Electronic Format — Standardized Study Data

The new guidance provides technical recommendations to sponsors for submitting animal and human study data and related information in a standardized electronic format in INDs, NDAs, ANDAs, and BLAs. FDA says it is intended to complement and promote interactions between sponsors and FDA review divisions. However, it is not intended to replace the need for sponsors to communicate directly with review divisions regarding implementation approaches or issues relating to data standards, it says.

“Because of the inherent variability across studies and applications, it is difficult to identify all data needed by a review division prior to a scientific regulatory review,” the agency says. “We recommend that as early as the pre-IND meeting, sponsors should use the established regulatory process to discuss with the review division the key data necessary to support a submission, the data elements that should be included in each dataset, and the organization of the data within the datasets.”

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,

Study Data Technical Conformance Guidance

Read more

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

Guide on Biosimilar Postapproval Manufacturing Changes

FDA Warns of Philips Ultrasound Malfunction Linked to Four Deaths