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How To Register With The FDA

The US FDA requires facilities who are engaged in manufacturing, processing, packaging or storing food pharmaceuticals, and medical devices sold in the United States to register with the FDA. Therefore, pharmaceutical and device manufacturers must list their facility and list the products. Companies must annual renew the registration and listings.  FDA US agent is required for foreign facility registration who can also assist for registration and listing. 

The number of laws and oversight can be very overwhelming if you are new to the US market. It’s much better to adopt from the very start instead of trying to fix mistakes after they’ve happened.

FDA Registration and listing   of Medical Devices:

You must register your organisation with the FDA if you are a supplier or initial distributor/importer of medical devices.

  • To register and list your information, log on to FURLS (FDA Unified Registration and Listing System). A user ID and password for accessing the FURLS must be available to the holder or operator. You will need to create one if you don’t have a FURLS account.

An experienced   FDA consultant can offer you services for medical device registration and listing which can save your time and efforts. 

FDA Drug  Establishment Registration  and NDC drug listing  

FDA Drug establishment registration is mandatory requirement for the companies who manufacturer, process , pack or hold the drug. Such facilities are also required to list the products manufactured in their facility. 

Private label distributors are required list the products which they distribute. 

It is mandatory requirement to renew drug establishment registration annually and update the drug listings between 1st October to 31st December  every year. 

Foreign drug establishments are required to appoint US Agent for FDA registration purpose. US Agent acts as point of contact between foreign company and FDA. US Agent plays important role for your business.

Food/drinks and dietary supplements registration requirements 

Each food company (domestic or external) manufacturing, storing, packaging or keeping food for consumption to humans in the United States shall register its company with the FDA. Facilities are also required to renew the food facility every even year such as 2020, 2022 …

FDA examples from “foods” which may be produced in a registration facility, but are not limited to how to Register Food & Diet supplements

  • Raw food products of the farm,
  • Drinks including alcoholic beverages
  • And water bottles of dairy products
  • And eggs dietary supplements 
  • Animal feeding-stuffs

A separate registration number is provided for each food facility. You might need to register and receive separate registration numbers for food facilities if you own or run many facilities. The second facility may also be required to register if your service is transferred to another installation.

Under the Food Safety and Modernization Act (FSMA), the international establishment will provide the FDA with a designated U.S. agent’s name and contact information. Such agents are the contact link between the food plant and the FDA.

FDA Cosmetic Industry Registration:

Cosmetic Registration, Voluntary Program (VCRP) is voluntary. Companies can market cosmetic products by complying with the below requirements. 

  • Cosmetics should not make disease curing or treatment  claim 
  • The product should comply with FDA labelling requirements for cosmetics  
  • The ingredient does not cause the cosmetic to be adulterated or misbrands
  • The product should be safe to use

FDA US agents will work with you to ensure the safety, proper labelling and enforcement of your goods and ingredients.

Draft Guidance Detailing Good Practices For The ANDA Submission

 On 3rd January 2018, Food and Drugs Administration (FDA) published a draft guidance detailing about the good practices for the submission of ANDAs (Abbreviated New Drug Application). This draft consists all of the important things to consider while submission along with highlighting the common deficiencies that may lead to a delay for approval. Mentioned below are some of the highlights from the draft guidance: –

  • The applicants are required to submit proper documents. Notice of paragraph IV certification, Legal action filing, etc should be considered and done in a specified time frame. Also, when a new patent is listed for a Reference Listed Drug, applicant should never file it as serial submissions of amendments to their paragraph IV certifications. 
  • The applicants are expected to properly submit the draft container labels. The container labels should have sufficient color differentiation for the different strengths of a drug product. For the parental drug, the applicant should propose package types which should not differ from the type approved by the RLD. 
  • It is must for the applicants to provide complete information in their form FDA 356h and in the correct modules in the application. Each and every manufacturing details should be mentioned, i.e. solubility data for the full physiologic pH range, full description of the of the proposed dissolution test, data demonstrating the dissolution methods discriminating ability and information for all strengths of the tests and reference products. 
  • It is suggested that in the bioanalytical study report, the applicants should include complete dilution integrity data, analytical raw data, serially selected chromatograms and all the standard operating procedures. If there are any differences in formulations and inactive ingredients existing, then the applicants should provide necessary justifications and documentations addressing these differences. Along with the clinical summary, it is also necessary to provide information on bioequivalence and safety related to in vivo bioequivalence studies. 
  • All the manufacturing processes and the impurities along with the quality control record and manual should be reproduced by the applicants. The parameters and the units should be mentioned clearly in the bioanalytical data. It is important to provide explanation about the inactive ingredient regarding why it should be there in the drug composition and in what limits it stays unaffected. 

For getting US generic approval on the already existing licensed medication, an ANDA application should be submitted with all the necessary documents in order to avoid any kind of failure or lack. It is essential to know the ANDA Submission Process very well to let it happen legally smooth. The FDA no longer accepts hardcopies of the application. Thus, the applicants must submit their ANDA applications in an eCTD format. The eCTD submission sizes 10 GB and less than this must use the FDA Electronic Submission Gateway (ESG).

Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures

The FDA stands for Food and Drug Administration. FDA is a crucial part of the US Department that is dedicated towards offering health and human services. The primary function of this organization is to oversee the production of foods, pharmaceuticals, medical devices, and other consumer products.  The development of biological commodities that are used for treating allergies and making cosmetics are monitored by this department. When a product is found to be unsafe to use, at that time the primary job of FDA is to issue recalls. The formation of this agency dates back to 1848 and it is The US’s oldest consumer protection agency.  The mission of this agency is to protect the Americans from the use unsafe and unhealthy products. The life of people is often endangered by harmful radiation that comes from electronic gadgets and devices. All those products that give off harmful radiation, they can only be need after getting a preapproval from the department. 

Continue reading Foreign FDA Inspections: A Guide to FDA’s Pre-Inspection Procedures

A Guide to ANDA Submissions Issued By The FDA

ANDA stands for Abbreviated New Drug Application. The ANDA submission is known to contains Chemistry, Manufacturing and Control information along with bio-equivalence data . The main purpose of the ANDA submission to the FDA is to review as well as ensure potential approval of generic drug the FDA. Once the drug or product receives approval, the applicant is given the freedom to manufacture as well as market the generic drug. The marketing of the specific drug product is aimed at providing a safe, cost-effective, and an effective alternative to the brand-name drug that has been referenced by the company.

Continue reading A Guide to ANDA Submissions Issued By The FDA

What You Need To Know About The FDA GDUFA Self Identification Requirements

Who is required to self-identify?

As per the federal law, FDA self-identification is going to start from May 1st, 2019 and the facilities are required to submit their files as soon as possible. Each and every Drug company is requested to update, re-confirm and submit the self-identification form before June 1st, 2019. The manufacturer or any company who plans to become a manufacturer of human generic drug APIs or FDFs are required to self-identify. Any organization or company that package the FDF of human generic drugs into the primary container/closure system will also have to go through this process. Continue reading What You Need To Know About The FDA GDUFA Self Identification Requirements

All You Need To Know Responsibilities Of An FDA US Agent

In the United States, FDA US Agent plays a vital role in regulatory compliance activities. Further, regulatory compliance has a direct impact on your business. It remains the U.S Agent’s responsibility to assist the FDA in communicating with foreign companies when such communication is necessary. U.S Agent should be capable of understanding FDA compliance related matters and effectively communicate with foreign companies. Also, U.S Agent should share any compliance action or FDA communication promptly with foreign companies. Continue reading All You Need To Know Responsibilities Of An FDA US Agent

All You Need To Know About The FDA Food Facility Registration

The Bioterrorism act that was introduced in the year 2002 is meant to check the flow of food and drugs under the Food and Drug Administration (FDA) which is one of the most popular food regulatory agencies in the world. These services were meant to protect the public from food-related emergencies and keep a check on the common issues among the people. Continue reading All You Need To Know About The FDA Food Facility Registration