FDA approval for pharma expert

Symbiosis secures FDA viral vector process approval for the manufacturing process at its site in Scotland

FDA invests in continuous manufacturing technology

FDA acquires GEA ConsiGma 1 unit for its CDER/OPQ Continuous Lab

Turmeric extract granted a ‘no questions’ letter from the FDA

BCM-95 is composed of pure curcuminoids and essential oils from turmeric with a specific content of turmerones

Meeting the systems integration challenges of pharma manufacturing

Effective use of automation can deliver a host of benefits, including higher quality, increased reliability, lower manufacturing costs

Compliance – more than just red tape

Lee Sullivan discusses the importance of compliance in the pharmaceutical industry and the role that regulations play in drug shortages and quality issues

New FDA-conforming diaphragm pumps

Pumps that are tailored to the needs of the pharmaceutical and cosmetics industry

FDA premarket approval of HCV genotyping test for Hepatitis C patients

Assay (provides improved accuracy in identification of HCV genotype and subtype for guiding selection of optimal therapeutic treatment for individuals with Hepatitis C

Traditional Chinese medicine seeks to receive FDA approval in US

Dantonic pill is a botanical product for the treatment of chronic stable angina pectoris due to coronary heart disease

How to avoid and respond to FDA criticisms

Ken Appel reports on how manufacturers can keep on top of regulations for temperature, humidity and controlled environments.

FDA ignores critical HIV information

The FDA is ignoring critical information in deciding whether to approve an over-the-counter, rapid HIV test for home use, according to a recent article.

FDA underlines commitment to post-marketing drug testing

Critical Path is a broad initiative at the FDA involving all of its medical centres. The effort is aimed at catalysing the creation of a new generation of scientific tools to enable product sponsors to better predict and evaluate the safety and effectiveness of candidate products.

Chip-based diagnostic test technology wins FDA approval

The US Food and Drug Administration (FDA) has cleared Swiss pharmaceutical and diagnostic company Roche's AmpliChip CYP450 microarray-based test for diagnostic use in the USA.

Ensuring digital image analysis in compliance with FDA 21 CFR 11

Dr. Manfred Kässens reports on how image analytical software has been adapted to meet the demands of the regulation entitled FDA 21 CFR Part 11.

Recipharm supplies clinical trial material for FDA approved phase IIb study sponsored by PledPharm

Recipharm and PledPharma announce FDA approval of an IND application for Phase IIb clinical trial with PledOx, PLIANT, in the U.S.





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