Cardiovascular Adverse Event Experts
Drug Development Experts
Clinical Trial Experts
Medical Literature Analysis
Statin/ Cholesterol Experts
Imported Drug Expert
Drug Pricing Experts
Generic Drug Experts
FDA Regulatory Affairs Contact Us
FormerFDA.com is an exclusive and specialized group of scientists and clinicians.
The FDA hires and employs only the most specialized, experienced and qualified individuals from academia and industry, and a career at the FDA is considered a highly sought-after "capstone" accomplishment for medical scientists, physicians or pharmacists of all specialties.
Other consulting groups dubiously claim to be able to give expert advice on drug applications, safety evaluations, and the FDA because they have experience as a scientist or executive working at a CRO or drug company, but most do not have actual hands-on, actual experience reviewing applications at the FDA.
At FormerFDA.com, we believe actually having long-term experience and actually having reviewed safety and efficacy concerns in an NDA makes a significant difference in understanding the thought process by which an application is reviewed.
In some cases, this depends on the personality of the medical officer or division director who reviews the application. In other cases, members of FormerFDA.com will personally know the reviewers in question, and know their historical thought patterns.
Although the FDA does release its decision to the public, it does not release its thought process as part of its disclosure. The best way of understanding and predicting the FDA decision process is by speaking to a former FDA Medical Reviewer or a former FDA Medical Officer.
All consultants at FormerFDA.com are verified to have been former FDA employees.
The Pharmaceutical Development Process
Pharmaceutical drug development is one of the most regulated processes in the world. The amount of regulation governing the drugs we take exceeds that of any other business model. The clinical fundamentals of drug development are simple in their essence. Simply stated: drugs must be efficacious and be safe.
FDA Medical Officers and FDA lawyers work hand to hand to ensure CFR 21 and 22 (Code of Federal Regulation) are followed explicitly, (an FDA lawyer duty) and that patients are protected and are taking a drug which is both safe and efficacious (FDA medical officer duty).
Prior to 1938, there was widespread promoting of worthless or even dangerous elixirs and tablets labeled as “medications” being touted on the streets and to pharmacies by charlatans with no medical or scientific background, which claimed to cure a wide array of diseases including influenza, heart disease and tuberculosis. With consistency, these products were neither safe nor efficacious.
Establishing safety and efficacy today is a significantly more elaborate and complicated process. Proving a drug’s efficacy and safety takes years to convince the FDA to grant approval, and safety and efficacy monitoring continues indefinitely following a drug’s FDA approval.
The development and safety monitoring process require very close attention to detail and a thorough knowledge of the Code of Federal Regulations and the safety and history of existing treatments and pharmacology.
Over the past 70-plus years, establishing efficacy has become significantly more elaborate and in its analysis and design. In establishing efficacy, drugs do not only have to prove that they work, they have to prove that that they are non-inferior to compounds that exist.
Although a drug has the potential to improve or protect an individual against a certain disease, there is always at least some risk to introducing a pharmaceutical product into the human body.