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FDA’s Portal To India

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Regulatory Compliance Digest

SacksOfSpicesA cursory look in our kitchens confirms the fact that it is indeed a small world after all.  Those of us living in the U.S. take know that as part of our daily routines, including the foods we consume.  India is a case in point.

According to the U.S. Commerce Department, nearly one quarter of the spices, oils and food colorings used in the U.S. comes from India.  Overall, in 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S.

It makes sense then that a high-level U.S. agency plays a prominent role in coordinating the interests of Americans in this ever-expanding global village.  As part of its broader regulatory functions, the U.S. Food and Drug Administration (FDA) works to ensure that foreign-produced foods and drugs are safe, effective and of good quality.

FDA Collaboration with India

As part of its response…

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FDA’s Portal To India

Posted on

Regulatory Compliance Digest

SacksOfSpicesA cursory look in our kitchens confirms the fact that it is indeed a small world after all.  Those of us living in the U.S. take know that as part of our daily routines, including the foods we consume.  India is a case in point.

According to the U.S. Commerce Department, nearly one quarter of the spices, oils and food colorings used in the U.S. comes from India.  Overall, in 2011, India was the second largest drug exporter and the seventh largest food exporter to the U.S.

It makes sense then that a high-level U.S. agency plays a prominent role in coordinating the interests of Americans in this ever-expanding global village.  As part of its broader regulatory functions, the U.S. Food and Drug Administration (FDA) works to ensure that foreign-produced foods and drugs are safe, effective and of good quality.

FDA Collaboration with India

As part of its response…

View original post 453 more words

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

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Quality means fitness for intended use. Pharmaceutical quality refers to product free of contamination and reproducibly delivers the therapeutic benefit promised in the label to the consumer. The Quality of the pharmaceutical product can be evaluated by in vivo or in vitro performance tests. Quality by design assures in vitro product performance and In vitro product performance provides assurance of in vivo product performance. “Hence Quality by design relate to Product Performance”.

see all at

http://www.askaboutvalidation.com/pharmaceutical-quality-by-design-qbd-an-introduction-process-development-and-applications/

Pharmaceutical “Quality by Design” (QbD): An Introduction, Process Development and Applications

Author-Mr. UMESH PATIL. Pursuing Master of Pharmacy (PHARMACEUTICS), KLE Society’s College of Pharmacy, Hubli. Karnataka.

Forest Announces U.S. Availability of New Once-Daily NAMENDA XR

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New Drug Approvals

 

memantine

Forest Announces U.S. Availability of New Once-Daily NAMENDA XR

— Treatment for moderate to severe Alzheimer’s Disease is now available to patients in a convenient extended release formulation —

NYSE:FRX.NEW YORK–(BUSINESS WIRE)–Forest Laboratories, Inc. announced today that NAMENDA XR(TM) (memantine hydrochloride) once-daily formulation is now available in pharmacies throughout the United States. NAMENDA XR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe dementia of the Alzheimer’s type.

http://www.pharmalive.com/once-daily-namenda-xr-launched-in-us

Memantine is the first in a novel class of Alzheimer’s disease medications acting on theglutamatergic system by blocking NMDA-type glutamate receptors. It was first synthesized by Eli Lilly and Company in 1968. Memantine is marketed under the brandsAxura and Akatinol by MerzNamenda by ForestEbixa and Abixa by Lundbeck andMemox by Unipharm. Memantine has been shown to have a modest effect in moderate-to-severe Alzheimer’s…

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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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