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Regulatory Aspects of Chemistry Manufacturing and Controls for Investigational New Drug Applications and Biologic License Applications to the United States Food and Drug Administration

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Figure 1. Pyramid of regulatory documents.

There is a bewildering array of information on the regulatory requirements for submitting an application to the Food and Drug Administration (FDA) from the FDA website, industry journal articles, webinars, and conferences. This article highlights critical aspects of the regulatory requirements for the Chemistry, Manufacturing, and Controls (CMC) section for Investigational New Drug (IND) applications and Biologic License Applications (BLAs). This article will draw attention to key regulations, guidance documents, and white papers. By no means is this article comprehensive; however, it will provide a global overview of the regulatory process from Phase 1 through Licensure.

2011, Pages 439–452

Volume 3: Industrial Biotechnology and Commodity Products


FDA Approves Xgeva,denosumab to Treat Giant Cell Tumor of the Bone

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New Drug Approvals

June 13, 2013 — The U.S. Food and Drug Administration today expanded the approved use of Xgeva (denosumab) to treat adults and some adolescents with giant cell tumor of the bone (GCTB), a rare and usually non-cancerous tumor.

GCTB generally occurs in adults between the ages of 20 and 40 years. In most cases, GCTB does not spread to other parts of the body but destroys normal bone as it grows, causing pain, limited range of motion and bone fractures. Rarely, GCTB can transform into a cancerous tumor and spread to the lungs.

Xgeva is a monoclonal antibody that binds to RANKL, a protein essential for maintenance of healthy bone. RANKL is also present in GCTB. Xgeva is intended for patients whose GCTB cannot be surgically removed (unresectable) or when surgery is likely to result in severe morbidity, such as loss of limbs or joint removal. It should only be…

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USP Defers Implementation of Elemental Impurities Provisions

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USP Defers Implementation of Elemental Impurities Provisions
USP defers implementation date to work closely with ICH Q3D. USP will also form a new advisory group for implementation of the new general chapters on elemental impurities.
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FDA Issues Draft Guidance on Contract Manufacturing at (

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The draft guidance describes how quality agreements can be used to delineate the responsibilities of contract manufacturers involved in the cGMP manufacture of APIs and finished drug products.

May 28, 2013
By: Patricia Van Arnum
FDA has issued draft guidance, Contract Manufacturing Arrangements for Drugs: Quality Agreements, which describes the agency’s current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in contract cGMP manufacturing of drugs.


eCTD Tools

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Budding Regulatory Professionals

May 18, 2013 – Related Posts Plugin for WordPress, Blogger… Follow Us Rethinking emerging markets for regulatory affairs with the … European Medicines

EMA Updates Inspector Expectations for API Audits

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EMA Updates Inspector Expectations for API Audits

As new API regulations are set in July for those outside the EU, the European Medicines Agency (EMA) has unveiled what its inspectors expect to see from API manufacturer or supplier audit reports from inside the region.