All posts tagged FDA

Clinical trial details that the US FDA is monitoring can be found at http://clinicaltrials.gov but if you want to see what’s happening in Europe check out http://clinicaltrialsregister.eu The European only launched recently (January 2016).

EU Clinical Trials Register


The FDA publishes Guidance for Industry documents. One such document is for the Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production which details guidance that applies to chemistry-based laboratory testing of drugs regulated by CDER. It is directed toward traditional drug testing and release methods.


According to the FDA 21 CFR 58.3 the definition of raw data is:

any laboratory worksheets, records, memoranda, notes, or exact copies thereof, that are the result of original observations and activities of a nonclinical laboratory study and are necessary for the reconstruction and evaluation of the report of that study. In the event that exact transcripts of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated, and verified accurate by signature), the exact copy or exact transcript may be substituted for the original source as raw data. Raw data may include photographs, microfilm or microfiche copies, computer printouts, magnetic media, including dictated observations, and recorded data from automated instruments.

FDA warning letters, known as Form FDA 483 is defined as

…a correspondence that notifies regulated industry about violations that FDA has documented during its inspections or investigations. Typically, a Warning Letter notifies a responsible individual or firm that the Agency considers one or more products, practices, processes, or other activities to be in violation of the Federal Food, Drug, and Cosmetic Act (the Act), its implementing regulations and other federal statutes. Warning Letters should only be issued for violations of regulatory significance, i.e., those that may actually lead to an enforcement action if the documented violations are not promptly and adequately corrected. A Warning Letter is one of the Agency’s principal means of achieving prompt voluntary compliance with the Act

They demand a prompt response from the organisation/company that receives such a letter. You can search the letters which are all published on the FDA website by clicking here.


In the USA the FDA regulates medical device manufacture and as part of this process classifies medical devices into one of three categories.

Class I: Most Class I devices and a few Class II devices are exempt from the premarket notification [510(k)]. They have only general controls and a few class I devices are even exempt from GMP requirements with the exception of complaint files and general record keeping requirements. Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.

Class II: These devices can have General Controls and Special Controls. Devices in class II held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, surgical drapes and an implantable radiofrequency transponder system for patient identification and health information.

Class III: This class of devices requires General Controls and Premarket Approval. They are generally the highest risk devices and are therefore subject to the highest level of regulatory control. Examples of Class III devices that currently require a premarket notification include: implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and dental implants.


Courtesy steveblank.com and Wikipedia

The video at the link below (courtesy Stanford University) is a short 3 min clip explaining the key differences between 510K medical device premarket notification and full premarket approval. The image below also outlines some of the other differences between the two as well.


Courtesy CDG Whitepapers

Below are links to actual product recalls by regulatory authorities illustrating the contents of a recall document.

FDA Recall Example

IMB Recall Example

The documents below out line the Eudralex and FDA GMP guidelines for dealing with complaints and product recalls.

Eudralex Guide to Complaints Product Recall

FDA Guide to Complaints and Product Recall

A qualified person (QP) is a technical term used in European Union pharmaceutical regulation (and therefore Ireland). The regulations specify that no batch of medicinal product can be released for sale or supply prior to certification by a QP that the batch is in accordance with the relevant requirements. (EudraLex, Volume 4, Chapter 1). In the USA there is no specific requirement from the FDA for a person specifically called a “qualified person” but the FDA requires that a company selects someone who is qualified to be the person who signs off on batches.

The Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors (familiarly known as the Orange Guide) is an essential reference work for all those involved in the manufacture or distribution of medicines in or for Europe. It is compiled by the UK drug regulatory body, the MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It therefore contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation.


The Orange guide is not available for free access but a sample chapter on premises and equipment can be found here. A full list of its index is also available here.

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book)  is a list that 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).

Did you know that when the first print edition of Approved Drug Products with Therapeutic Equivalence Evaluations was being prepared October 1980, staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggested, “It’s almost Halloween. How about orange?” Before long, The Orange Book had become a popular short title for this important publication. Courtesy FDA

The downloadable Orange Book “list” can be found here:


Here is a link on the FDA website of an example of a warning letter:


25-09-2013 13-25-30

And some more info and FAQ’s related to FDA 483 forms and Warning Letters