Sunday, March 8, 2015

SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies | The National Law Review

Read the full article: SEC Enforcement Director Discusses Issues for Pharmaceutical and Medical Technology Companies | The National Law Review:

"In a wide-ranging speech on Tuesday, Securities and Exchange Commission Director of Enforcement Andrew Ceresney discussed recent SEC actions and current concerns involving the pharmaceutical and medical technology industries. Ceresney’s speech is noteworthy because it highlights areas that are getting particular attention from the SEC’s Enforcement Division, namely the Foreign Corrupt Practices Act, internal controls and accounting, and disclosure of dealings with the Food and Drug Administration."

'via Blog this'

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Saturday, March 7, 2015

Advanced GMP Training For Leaders - The Executive Session

"Executive Session" is an advanced cGMP training course that addresses CGMP & QSR issues directly relevant to the executive leadership and management teams of manufacturers.

It can be hard to get busy executives into GMP training, even with the FDA citing companies for their executive team’s lack of CGMP training.
  • This course is designed to meet their busy schedule. 
  • Lasting 1-4 hours, this onsite class reviews current citation trends and compliance issues important to the busy executive. 
  • This course is completely customized for your company. 
Call Allan Dewes (SkillsPlus Intl Inc. 415-948-5220) to discuss your executive training needs.
Learn more about Executive Session - Advanced GMP Training For Leaders

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Monday, March 2, 2015

FDA Orange Book - 2015 (35th Edition) - New!

FDA Orange Book

Recently posted on FDA.gov:
The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations - 35th Edition (2015) - PDF

According to this "Orange Book" (aka "the List"):

"The products in this list have been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act. This volume is current through
December 31, 2014.

The publication, Approved Drug Products with Therapeutic Equivalence
Evaluations (the List, commonly known as the Orange Book), identifies drug
products approved on the basis of safety and effectiveness by the Food and
Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
Act). Drugs on the market approved only on the basis of safety (covered by
the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal®
Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital
Tablets]) are not included in this publication. The main criterion for the
inclusion of any product is that the product is the subject of an application
with an effective approval that has not been withdrawn for safety or efficacy
reasons. Inclusion of products on the List is independent of any current
regulatory action through administrative or judicial means against a drug
product. In addition, the List contains therapeutic equivalence evaluations
for approved multisource prescription drug products. These evaluations have
been prepared to serve as public information and advice to state health
agencies, prescribers, and pharmacists to promote public education in the
area of drug product selection and to foster containment of health care
costs. Therapeutic equivalence evaluations in this publication are not
official FDA actions affecting the legal status of products under the Act. "

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