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Newsletter - March 7, 2019

FDA Comes to the Defense of India-Based Manufacturers

In an unprecedented press release, FDA’s top officials refuted claims that quality of drugs manufactured in India and China are suspect. Rather they presented the strongest case ever, made openly by FDA officials, in support of the reliability of products manufactured in India.... Read More

Keep Using Expired Forms Unless FDA Says Otherwise

FDA uses several forms intended to be used for various regulatory applications. These regulatory forms are protected from alteration and need to accompany applications for appropriate processing. All FDA forms usually have a three year expiration which means every three years an updated version... Read More

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