FDA released guidance in May 2019 to help sponsors demonstrate that a proposed therapeutic protein product is interchangeable with a reference product when submitting a marketing application or supplement under 351(k) of the Public Health Services Act. The guidance provides an overview of scientific co...
While EU and FDA GMP Guidance is very similar, there are also some areas where there are known differences. It is worthwhile being aware of these differences and how to prepare for inspections and interaction with companies and authorities from the"other side". 虽然EU与FDA的GMP指南非常相似,但...
FDA publishes new guidance for Phase I clinical trials.(Clinical supplies/GMPs)Nathans, Carrie
1This document is intended to provide guidance. It represents the Agency’s current thinking on this topic. It does not create nor confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the ...
Through December 2017, Health Canada and FDA also are working to align their thinking on guidance documents from the International Council on Harmonisation (ICH) via joint public consultation meetings that are expected in September 2016, April 2017 and September 2017. ...
On December 18, 2023, the U.S. Food and Drug Administration (FDA) launchedCosmetics Direct, an electronic submission portal for product listing and facility registration required under the Modernization of Cosmetics Regulation Act (MoCRA). The agency also issuedfinal guidancewith recommendations to ass...
Summary This chapter contains sections titled: FDA Regulations: Real and Imagined 21 CFR 210 and 211: Current Good Manufacturing Practice for Finished Pharmaceuticals Guidance for Industry: Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations Guidance for Industry: PAT—...
but only a draft guidance has been issued as of yet). Until the Secretary issues the final GMP regulations for 503B Compounding Pharmacies, which will likely mimic drug GMPs, especially in sterility assurance controls, the FDA will continue to enforce 21 CFR 210 and 211 GMPs for d...
Quality/GMPs Upstream Processing Choose Specialty November 5, 2014 ByBioPharm International Editors Article FDA gives orphan drug designation to Merrimack Pharmaceuticals' MM-141 for the treatment of pancreatic cancer. Merrimack Pharmaceuticals announced on Nov. 5, 2014 that FDA has granted orphan drug ...
This control all manufacturing steps, validate critical process steps approach is embodied in the draft FDA Guidance for Industry on the Manufacture, Processing or Holding of Active Pharmaceutical Ingredients, which was released for public discussion on September 20, 1996. The latter can be obtained ...