FDA Approval Process Builds Safety into Its Design

John Klein brings three decades of pharmaceutical industry experience to his current position as chairman of Cambridge Therapeutics. In addition to his service with Cambridge Therapeutics and other for-profit companies, John Klein guided the United States Food and Drug Administration (FDA) approval process for hundreds of new drugs and supplements as a past chairman of the Worldwide Generics Pharmaceutical Industry Association.

The FDA’s Center for Drug Evaluation and Research (CDER) is the conduit through which new medications must pass before they are approved for sale and use within the US. It typically takes about a decade to approve a new drug but that lengthy process helps to ensure that only the safest and most effective medications reach the market. 

Before a drug can even be considered by the CDER team, its manufacturer is first required to conduct thorough rounds of testing according to established protocols. After the CDER receives the documentation noting the test results from a pharmaceutical company, its own cadre of scientists begins to conduct a complete review.

To file an application to have a drug approved for sale, the pharmaceutical company must demonstrate that the drug treats a specific condition and is safe for use by human beings. The company must provide evidence about the drug derived from clinical trials. Its application must also include safety and potential for abuse, directions for patient dosage, and the label information.

Generic Medications Offer Brand Name Strength with Lower Costs

As chairman of Cambridge Therapeutics in Teaneck, New Jersey, John Klein oversees the development of innovative drug delivery systems and combination therapy medications. John Klein’s 30 years of pharmaceutical experience include service in an executive capacity with multiple firms, as well as his work chairing the Worldwide Generics Pharmaceutical Industry Association. 

Generic medications are created according to the same formulations as Food and Drug Administration-approved branded drugs. Their level of effectiveness, safety, and quality, and the way they address illness within the human body are identical as well. Generic medications must undergo lengthy testing and FDA approval before released to the market.

In fact, an entire arm of the regulatory body – the FDA Generic Drugs Program – is designed to subject new generics to the same stringent controls that are applied to brand-name medications. Generics offer the advantage of often being far less expensive than their brand-name counterparts because they are not advertised and are packaged in nondescript containers. 

As each new drug enters the market, it receives a brand name and a generic name. The originating company markets the medication under its brand name. After that company’s patent expires, other firms may manufacture it under the generic name.

Title 21 of the Code of Federal Regulations

Based in Teaneck, New Jersey, John Klein leads Cambridge Therapeutics as chairman. John Klein has strategically guided Cambridge Therapeutics in this role since 2011, relying in part on his knowledge of the Code of Federal Regulations put out by the US Food and Drug Administration (FDA). 

In order to enforce federal requirements governing medical devices and products that emit radiation, the FDA develops and implements regulations for the industry. These regulations are first published online in the Federal Register and ultimately printed in the Code of Federal Regulations (CFR), which is published annually. 

The CFR comprises 50 titles that cover a broad spectrum of regulations. Title 21 (Parts 800-1299), which applies to medical devices and radiation-emitting products, includes specifications for the design, clinical evaluation, manufacturing, packaging, labeling, and after-sale tracking of medical devices. Title 21 also covers relevant standards and required reporting for products that emit radiation.

Pharmaceutical Quality Assurance via Contract Manufacturing

John Klein serves as the chairman of Cambridge Therapeutics, a health care technology company in Teaneck, New Jersey. With experience that encompasses contract manufacturing for pharmaceutical products, John Klein has worked with Food and Drug Administration-approved contractors across the globe.

Owners of contracted facilities where pharmaceuticals are made are responsible for ensuring that approved products satisfy all requirements and that deficient products are rejected before release. Similar to a quality-control process, contract manufacturing necessitates executive verification that all products are produced, packaged, and distributed in compliance with FDA regulations. In addition, the quality unit that checks the products for compliance must have its procedures and professional obligations clearly articulated in writing.

Known as quality agreements, these documents outline the products to be produced and their quality specifications, as well as the communication process between the owner and the contract facility. Comprehensive quality agreements also should cover subcontractor responsibilities, the process for making changes to processes or equipment, and guidelines for audit practices.