May 25, 2024

If your product is an over-the-counter drug or a medical device before you can market your products and sell it to the public, you need to get approval by the FDA or the US Food and Drug Administration. Food products and cosmetics do not usually need FDA approval unless it’s for color additives used in food, drugs, cosmetics, and medical devices. Although the application has been quite easier in recent years, the resubmission of applications has been very high.

The FDA Approval Rate of Initial Applications

According to the study done by Leonard Sacks, Hala Shamsuddin, and Yuliya Yasinkaya in 2014, 50{9aec2f3753136e72632b4743edb3bd445b461a73e7aee1730978bb7c413976bd} of the applications from 2000 to 2012 has been disapproved in the first cycle. Out of the failed applications, 47{9aec2f3753136e72632b4743edb3bd445b461a73e7aee1730978bb7c413976bd} obtained approval after a hundred days of delay, ranging to several days up to 2,374 days. 73.5{9aec2f3753136e72632b4743edb3bd445b461a73e7aee1730978bb7c413976bd} of the applications from 2000 to 2012 has been approved, but more than half of it needed more cycles of review, which usually cost the applicant entity time and resources.

A lot of the applications has been denied by the US Food and Drug Administration because of issues in dose selection, efficacy, and safety. Problems in manufacturing, controls, and labeling that can be prevented with proper guidance are also one of the reasons for disapproval of the application. Labeling and CMC deficiencies are enough to disapprove even an entry despite the drug’s safety and efficacy.

5 Reasons To Get A Law Professional For FDA Application

1. Ease of access to essential forms, letters, and other documents

Legal forms, letters, and needed documents are essential to the FDA approval application. It is recommended that before you actually send an application, all the proper documents are already prepared. To help you prepare your documents, there are FDA lawyers that offer assistance.

2. Source of practical advice before, and after application

A lot of lawyers with experience in the US Food And Drugs Administration know their ways around pharmaceuticals and biologics regulations. Because of this, they can offer assistance in legal matters regardless if the company is on early-stage or is already a mature global pharmaceutical company. In addition, they can also help in checking for compliances to ensure that all stones are left unturned.

3. Getting A Pre-Market Approval

Just like any other products being offered for public consumption or usage, getting an FDA approval will also be subjected to regulatory systems. It is important to ensure that your company is following the right regulations to avoid getting delayed. A law professional with FDA experience can help in preparing and filing product submission, premarket notification submissions, and modifications, as well as checking other things such as what type of submission is necessary and what product modification or materials can prevent approval.

4. Lawyers can help in transactional assistance

Law professionals can also offer different types of assistance related to medical devices, pharmaceutical, and biotech companies of any size. This transactional assistance includes outsourcing, mergers acquisitions, financing, and other transactions that might arise in the future.

David Page For FDA Application And Other Legal Matters

David Page is one of the law professionals who offer services and assistance to help drug manufacturers get their FDA applications approved. He served as a Senior Partner in Woolfson Weinstein for five years and spent seven years as Regulatory Compliance Director and General Counsel at Cupron Inc. Page got his law degree in University of Chicago Law School, as well as degrees in from Humboldt University and Harvard College. David Page is currently licensed to operate in both Israel and New York state. He is also the owner of the site InsideOutside Counsel which offers legal counsel online. You can contact him at or call at  +1-917-728-1682.