Lendle

Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consisten… more

Manage regulatory commitments, meet key deliverable dates, generate supporting data reports, support the financial forecasting process. This remediation project management guide provides a systematic approach to managing and tracking the m… more

A handy portable version of the Pharmaceutical Current Good Manufacturing Practices (cGMPs) – 21 CFR Parts 210 and 211. Plus the regulations for Electronic Records and Electronic Signatures – 21 CFR Part 11. Otherwise known as “FDA Regulati… more

Written by an expert for those who must design validatable cleaning processes and then validate those processes, this book discusses interdependent topics from various technical areas and disciplines. It shows how each piece of the cleaning… more

Ever wondered what these 0 calorie drinks we all indulge in once in a while are truly made out of? Are they really safe to consume? How could they be 0 calories and still taste so sweet? Discover all the answers in this book!It’s time we fi… more

This guide gives the basic facts about the different kinds of FDA-approvedmedicines and devices for birth control. This booklet give vital information such as brand and generic names, general side effects and warnings, and questions to ask … more

This revised edition of a bestseller provides a logical, step-by-step guide to testing new drugs and treatment modalities in compliance with the latest FDA regulations. With current forms, ICH GCP information, FDA regulations, and other ref… more

A handy portable version of the Medical Device Current Good Manufacturing Practices (cGMPs) – 21 CFR Parts 810 and 820. Otherwise known as “FDA Regulations”. Great for on-the-spot reference or for compliance auditing. The next time someone … more

This book guides the reader through FDA regulation guidelines and outlines a comprehensive strategy for cost reduction in regulatory affairs and compliance. This book explains six strategies to cost-effectively comply with FDA regulations w… more

Implementation of FDA’s Design Control requirements (21 CFR 820.30) changed an entire industry. Quality System Requirements defined the approach to medical device validation. Product design, manufacturing process, and test method validation… more

The goal for this book is to give you an easy-to-read, condensed, yet comprehensive case for the freedom to use drugs that are only part way through the long FDA approval process. After reading this book, you will have a working knowledge o… more

I believe everything my doctor tells me, without question. Right!!! There isn’t anything about how to make me well that my doctor doesn’t know. Right!!! If the AMA, FDA or other government agency approves it, I have to believe it’s both sa… more

Free To Choose Medicine offers a compelling argument for the freedom of every patient, guided by the advice of his or her doctor, to make informed decisions about the use of not-yet-FDA-approved therapeutic drugs that are in late stages of … more

I believe everything my doctor tells me, without question. Right!!! There isn’t anything about how to make me well that my doctor doesn’t know. Right!!! If the AMA, FDA or other government agency approves it, I have to believe it’s both sa… more

When first published in 1999, Your Drug May Be Your Problem was ahead of its time. The only book to provide an uncensored description of the dangers involved in taking every kind of psychiatric medication, it was also the first and only boo… more

“The CAPA (Corrective Action/Preventive Action) Quality subsystem is the most audited by FDA inspectors. This book is designed to help Quality management professionals in Biomedical, Pharmaceutical, Tissue, and Medical Device industries des… more

The expose of the meat packing industry which led to the formation of the FDA and numerous reforms. Slaughterhouses were once staffed by poorly paid immigrants who worked long hours under horrible conditions. This is a true story.

“Next to CAPA,change control is the most audited Quality subsystem by FDA inspectors.Failure to have a robust change control system exposes the organization to regulatory compliance risk,it encourages waste of company resources,and increase… more

Small cap biotech companies spend hundreds of millions of dollars and over ten years moving experimental drug candidates from concept to fully approved drugs. For late stage drug candidates, those in Phase III, positive or negative data can… more

This booklet gives vital information such as brand and generic names, general side effects and warnings, and questions to ask your health care provider. Use this guide to help you talk to your doctor, pharmacist, or nurse about your medicin… more