Tags » FDA Regulations

Webinar On FDA Compliance and GAMP V Computer System Classification

Scheduled On : Wednesday, January 13, 2016 at 13:00 Hrs 

Description :

You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. 382 more words

Life Science

Webinar On FDA's New Enforcement of 21 CFR Part 11

Scheduled On : Wednesday, January 13, 2016 at 13:00 Hrs      

Description :

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program. 279 more words

Life Science

Requisitos de la FDA para Exportar Alimentos y Bebidas a los EE.UU.

Únase a Registrar Corp el Martes 27 de octubre de 2015 en el 19ª Americas Food and Beverage Show en Miami, Florida, para aprender cómo exportar alimentos a los EE.UU. 96 more words

2015 AFB Showcase And Conference

Court approves Vascepa® for off-label use despite pushback from FDA

On Friday August 7th, the Southern District Court of New York permitted Amarin Pharma to promote certain off-label uses of its 2012 FDA-approved drug, Vascepa®. The FDA has made it known that promoting uses of drugs that are not on FDA-approved labeling violates the Food, Drug, and Cosmetic Act (FDCA). 474 more words

Property & Casualty

Thoughts on Warning Labels and Child-Resistant Packaging for E-Liquids

Well, what can I say? At least, the FDA is considerate enough to post an advance notice of proposed rule-making (ANPRM) to let everyone concerned know that they’re going to make it harder and more expensive for e-juice vendors and manufacturers to sell their products. 878 more words

Personal Vaporizors

Webinar On FDA Inspection and Medical Device Design Control

Scheduled On : Tuesday, July 28, 2015 at 13:00 Hrs  

Description :

Medical device firms are subject to design control requirements.  According to the recent FDA enforcement trends (including 2013), inadequate design control is frequently cited in 483s and FDA warning letters. 356 more words

Medical Device

The inherent risk surrounding nutraceuticals

Nutraceuticals, a $30 billion industry in the United States, come in the form of capsules, bars, drinks, lotions, pills, and powders. The medical and therapeutic benefits they claim to offer vary from renewed sexual drive, to enhanced athletic performance, to fewer wrinkles. 395 more words

Property & Casualty