FDA Submissions

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FDA Submissions

FDA Submission Process

Compiling an FDA submission is not easy. It is a time-consuming and arduous process, and if the submission contains mistakes or inaccurate information, your product’s future may be at risk. However, if you put in the hours to make sure the submission is error free, your time-to-market will likely be much shorter.

The Weinberg Group: FDA Submission Experts

In order to make sure you get it right the first time, The Weinberg Group will combine our knowledge and experience to plan and coordinate every detail of a clear and complete FDA submission. There are many elements that go into the submission, but most importantly, a combination of administrative and technical information must be accurately presented to prevent any delays or issues with review.

FDA Submission Service Offerings

We provide consulting services for key FDA regulatory submissions including:

Understanding IND Applications

Investigational New Drug (IND) approval is the first step towards being able to begin your clinical trials. Getting here required hard work and a great pre-IND meeting strategy.

The sooner you can begin your clinical trials, the sooner your product will be on the market, and in order to prevent any hiccups in this process, your final IND submission must be error free and contain all of the required information.

How to Meet IND Filing Requirements

Your IND application will request authorization from the FDA to administer an investigational drug/biological product to humans and must be reviewed before you transport your product across state lines to clinical sites. The requirements for an IND submission are complicated and can be hard to understand. The Weinberg Group will work with you to make sure your IND application meets these stringent requirements and contains all of the following components:

  • Form FDA 1571 and 3674
  • General investigational plan
  • Investigator’s brochure
  • Protocol(s): study protocol(s), investigator data, facilities data, Institutional Review Board (IRB)
  • Chemistry, Manufacturing and Control (CMC) data, including environmental assessment or claim for exclusion (assuming the draft of CMC information exists)
  • Nonclinical: pharmacology and toxicology data
  • Clinical: previous human experience
  • Additional information to support the IND filing

Together, we will carefully review the IND application and our staff will provide you with a final copy that is FDA ready.

505(b)(1) vs. 505(b)(2) Pathway

The 505(b)(1) regulatory pathway is the traditional New Drug Application (NDA). This pathway is used to obtain the approval of a new drug whose active ingredients have not previously been approved. As you can imagine, this type of submission requires extensive research including both clinical and nonclinical studies to prove the product’s safety and efficacy for the indication being sought. Because of the substantial amount of research and data that is required, 505(b)(1) NDA submissions can take many years to complete, and require a significant amount of resources to get approved.

The 505(b)(2) regulatory pathway is another type of NDA submission that can be used to obtain the approval of a new drug. This type of submission differs from the 505(b)(1) NDA in that the product in question contains similar active ingredients to a previously approved drug. As such, the data included in the submission can rely, at least partially, on the Agency’s findings of safety and effectiveness related to another product. Sponsors taking advantage of the 505(b)(2) regulatory pathway can experience a shorter drug development program that requires less resources than the 505(b)(1) regulatory pathway.

Choosing the Appropriate Regulatory Pathway

When deciding which regulatory pathway is best for your NDA submission, the following questions should be considered:

  • Does the product consist of a New Chemical Entity (NCE)?
  • Is the product a new or novel formulation?
  • If it is an existing product, is it a new route of administration?
  • Does any published literature exist?

While this is by no means an all-inclusive list, answering these four questions will help you to determine which regulatory pathway is most appropriate for you and your product, which is a critical step in the development and submission of an NDA.

Benefits of Having a Regulatory Consultant

Choosing the right regulatory pathway is critical to the success of your submission. It is of the utmost importance that you take all precautionary measures to ensure that you are headed in the right direction. We can help you do this. The Weinberg Group has significant experience in helping our clients determine the most appropriate regulatory pathway, and then develop and submit the application to the FDA.

Using our unique approach that combines vast regulatory experience with a deep scientific knowledge, we have had overwhelmingly high success rates when dealing with the Agency. By partnering with us, some of the benefits you will receive include:

  • Experience – we have been working directly with the FDA for more than 34 years.
  • Knowledge – we know what is required to achieve a successful interaction with the Agency, and are uniquely qualified to work with you in preparing and submitting an extraordinary submission.
  • Diversity – our team of scientific and regulatory experts specialize in a variety of disciplines and stay abreast of changing and trends and current events within the industry. Because of this, we are able to bring a unique and extensive range of knowledge and experiences to the table, which is exactly what is needed to develop an application that will be successful.
The Weinberg Group: Expert Guidance for 505(b)(1) & 505(b)(2) Submissions

After developing your regulatory strategy, you know which new drug pathway – 505(b)(1) vs. 505(b)(2) – to use to take your product to market. For those taking the 505(b)(1) route, The Weinberg Group will help you develop your application, including all information necessary to demonstrate the safety and efficacy of your new active ingredient. This process will take time and guidance, and supporting information will need to be generated through clinical studies.

On the other hand, if you are planning to submit a 505(b)(2) application, your time to market will be remarkably less due to the fact that you are able to rely, in part, on data from existing reference drugs. Our staff will work with you to ensure your product only differs from an approved drug in the following ways:

  • Dosage form
  • Strength
  • Route of administration
  • Substitution of an active ingredient in a combination product
  • Formulation
  • Dosing regimen
  • Active ingredient
  • Combination product
  • Indication
  • Rx/OTC monograph
  • Naturally derived or recombinant active ingredient
  • Bioequivalence

Afterwards, we will guide you through the entire 505(b)(2) application, using our vast knowledge of and past experience with the FDA to create a seamless filing process.

Getting an orphan designation can be a challenge, and just the designation is not enough. You must get and translate that knowledge into regulatory and drug development efforts to really make a difference.

The Weinberg Group will thoroughly evaluate and examine all relevant documents, including product information, scientific articles, public-domain information, disease prevalence data, etc. in order to identify whether or not your drug qualifies as orphan. If we recommend proceeding with an Orphan Drug Designation application, we will build on the information we obtained to develop and submit the application, on your behalf, to the FDA’s Office of Orphan Product Development (OOPD). If your orphan drug application is approved, your product will enjoy:

  • Seven years of marketing exclusivity when the product is approved
  • Protocol assistance
  • Tax credits covering up to 50 percent of clinical trial costs
  • Research grants to help fund clinical investigations for orphan products
  • Waiver of the PDUFA application fee

To learn more about how The Weinberg Group can help you develop a reviewable, complete FDA submission, contact us today.