What is ANDA?
ANDA is the Abbreviated New Drug Application, the FDA's generic drug approval process.. .... Read More
Who should file ANDA?
Any companies interested in obtaining generic drug approval should file ANDA.. .... Read More
What is a generic drug?
A generic drug is identical–or bio equivalent–to a brand name drug (already approved by FDA) in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.. .... Read More
What information should be included for ANDA?
Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.. .... Read More
How much is ANDA fee?
|Large Size||. .... Read More|
What is the time frame for approval for ANDA Applications?
Who should register?
As per 21 CFR 207, domestic and foreign establishments that manufacture, repack, or re-label drug products in the United States are required to register with the FDA.. .... Read More
What information is required for Establishment Registration?
The contact address and DUNS number are required for Establishment Registration. Non US-companies are also required to provide US Agent information. If required, we can act as US agent for your company.. .... Read More
Does the FDA issue Certificates of Registration?
No. The FDA does not issue any certificates. You can verify your company registration at the below link: http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm. .... Read More
How long will it take for Establishment Registration?
Generally, it takes two to three working days.. .... Read More
What are the fees for Establishment Registration?
How can Pragmatic help with Establishment Registration?
We prepare the establishment registration SPL on behalf of your company and submit to the FDA through our ESG gateway. We also provide US Agent services for non-US companies.. .... Read More
When do we need to renew Drug Establishment Registration?
Establishments must renew their registration annually, between October 1st and December 31st of each year.. .... Read More
What is the Labeler Code?
This is the number assigned by the FDA to the manufacturer /packer/labeler of the drug.. .... Read More
What is a Drug Listing?
Drug listing is the process of providing product and labeling information to FDA in electronic format.. .... Read More
What Is NDC Number?
What is NDC Number (National Drug Code) ? NDC number is 10 digit numerical code assigned to drugs. First 5 digits of the NDC number come from the labeler code. Labeler code is assigned by the FDA to manufacturer , distributor or brand owner of the product. The first step for NDC number is to obtain the labeler code from FDA. .... Read More
Who needs a Drug Listing?
The owner or operator of an establishment entering into drug manufacture or preparation.. .... Read More
How much time does it take to obtain the NDC number?
This process takes around 48 hours.. .... Read More
How much time will Drug Listing take?
Once we have the information, the process takes two to three days.. .... Read More
How can you help me with Drug Listing?
We provide a complete service for drug listing and NDC numbers. We will support you through each stage of the process, until your registration is complete.. .... Read More
What information do I have to provide for Drug Listing?
For drug listing, we need the following information:
What are your fees for NDC assistance ?
Our fees for NDC number assistance are $199.. .... Read More
What are your fees for drug listing?
Our fees for drug listing are $250.. .... Read More
Who needs to self-identify?
All facilities involved in generic drug manufacturing (including API manufacturing), packing, testing and bio-equivalence testing are required to self-identify.. .... Read More
What about fees for self-identification?
Only facilities that manufacture, or intend to manufacture, generic drug APIs, FDFs, or both, are required to pay facility fees. Sites and organizations that only perform testing, repackaging, or re-labelling are not required to pay a user fee.. .... Read More
What information is required for self-identification?
Basic contact information is required, along with information about the nature of the operations - for example, FDF manufacturing or API manufacturing testing.. .... Read More
How can I very my self-identification status?
The FDA publishes a list of all self-identified facility addresses, along with their type of business.. .... Read More
How much time will it take to self-identify my facility?
With our support, the self-identification process takes about 48 hours.. .... Read More
When Should I Self-Identify?
You should self identify if you are performing generic drug-related activities, including manufacturing, testing, or clinical studies. It is more important to know when you should self identify. Our services can save you time and money.. .... Read More
How we can help to market your medical device?
Pragmatic supports companies to classify their medical devices and identify the applicable regulatory requirements. Our complete solution takes through each stage of the requirements.. .... Read More
What are the requirements for marketing medical devices in the United States?
This depends on the type of medical device you are intending to market. The FDA has established both general requirements and special requirements. General requirements include establishment registration, device listing, proper labeling and GMP, which are applicable to most devices. Special requirements – such as Pre market notification and Pre market approval – are applicab. .... Read More
Can the FDA inspect cosmetics manufacturers?
Yes. The FDA can and does inspect cosmetic manufacturing facilities to assure cosmetic product safety and to determine whether cosmetics are adulterated or misbranded under the FD&C Act or FPLA.. .... Read More
What do cosmetics firms need to do?
Under the law, cosmetics manufacturers are not required to register their cosmetic establishments or file their product formulations with the FDA, and no registration number is required to import cosmetics into the United States. However, we encourage cosmetic firms to participate in the FDA’s Voluntary Cosmetic Registration Program (VCRP) using the online registration system. .... Read More
FDA US Agent
. .... Read More
Are there any hidden fees?
No. Our fees are transparent and there are not hidden charges.. .... Read More
Do I need a US Agent?
US Agent appointment is mandatory for all foreign companies who wish to market their drug, food or medical device products in the United States. In the vast majority of cases, the FDA communicates with companies through the US Agent.. .... Read More
How much time will it take to appoint a US Agent?
We can complete the US Agent appointment formalities in just 20 minutes, using through our online system. As soon as you provide your company information and make the payment, we can give you US Agent details to include in your regulatory submission or registration. Click here Read More
How much is the US Agent fee?
Our standard US Agent fee is $299 for one year. However, if your company has potential regulatory submissions which might include NDA, IND, ANDA, Controlled Correspondence, or PMA, then fees may be more, as these services require more frequent involvement of the US Agent. Read More
Responsibilities of US Agent
Our Services for GDUFA Self Identification Requirement
How our company help you to meet self identification requirement ? FDAbasics can offer you complete support for self identification of your facility to comply with GDUFA requirements. We shall assist you to obtain the FEI number which is mandatory requirement for GDUFA self identification of your facility. We just don't submit your self identification, we also provide guidance on when. .... Read More
What is a Drug Master File?
A Drug Master File – or DMF – is FDA's provision to submit confidentiality information on the chemistry, manufacturing and control information about a product for the agency's evaluation.. .... Read More
How we can assist for DMF submission to FDA?
Pragmatic offers a complete solution for all types of DMF submission to the FDA. We offer DMF review, compilation, technical gap analysis, eCTD conversion and submission through ESG. We also provide services for management throughout the lifecycle of a drug master file. Please contact us for more information.. .... Read More
How much time is required for DMF submission?
The timeline for the DMF submission depends on the availability of technical documents. If you have all the documents – including Batch records, Specification, Method of analysis, In process specification, Raw material specification and testing reports, Impurity profiling, Batch analysis data, and stability study – it will take about 10 working days to compile the DMF in eCTD format and submit. .... Read More
How much is the DMF Fee ?
DMF fee is applicable only for type II DMFs (API or Drug Substance). There is no fee charged by FDA for packing material or excipient DMF. FY 2019 , DMF fee is $ 55,013. This fee should be paid well before referencing your DMF in your ANDA application. However, you can still submit the DMF to FDA without paying the fees and wait for the ANDA sponsor. After you pay the type. .... Read More
How we can assist you?
Pragmatic offers complete solutions to comply with all the FDA requirements: US agent services, food facility registration, labelling review, and guidance for GMP compliance requirements. Please contact us for more information.. .... Read More
How much time is required for food facility registration?
After you have provided the required information, it takes about 48 hours to complete the food facility registration.. .... Read More
Does each food or dietary supplement require separate registration?
No. There is no such provision in the regulatory framework to register each dietary supplement since it is not required by law. Food facility registration is the one of the FDA's requirement as per Public Health Security and Bioterrorism Preparedness and Response Act of 2002.. .... Read More
What are the FDA requirements for food
[caption id="attachment_1317" align="alignnone" width="543"] FDA Requirements for Food Products[/caption]
FDA req. .... Read More
What is FSVP ?
FSVP stands for Foreign Supplier Verification Program.FSVP is one of the requirement as per FSMA rule, which requires importers in the United States to verify their foreign supplier. .... Read More
FDA Biennial Registration Renewal period Food Facility
When is the FDA Biennial Registration Renewal period for Food Facility ?Food facility registration must be renewed every even calendar year, between October and December. Example : If you have submitted initial registration in the month of September 2017, then you must renew food facility registration before December 2018 and your next renewal will be i. .... Read More
FSVP Agent (FSVP Importer) – FSVP requirements
An FSVP Agent or FSVP importer is an individual or a company, residing or maintaining a business in the USA, who is the designated representative of a foreign supplier for FSVP compliance purpose. Read More
How can I market food products?
In order to market food products in the United States, you must first comply with the following requirements:
eCTD Requirements and cost effective solutions
Electronic Common Technical Document -eCTDeCTD is a harmonized regulatory filing format widely accepted by several countries. ICH adopted countries have common modules 2,3,4 and 5 and customized administrative module 1 according to country specific requireme. .... Read More
How to Renew FDA Registration
[caption id="attachment_1646" align="alignnone" width="300"] FDA[/caption] Answer to your question depends on , whether your product is Food, Medical Device or Dr. .... Read More
How to search FDA registration number
Answer to the question "How to search FDA Registration Number" depends on the type of product. FDA has maintained the database for medical device and drug establishment registrations, whereas there is no online searchable database for food facility registration.
Here are the step by step inst. .... Read More
What should you know about DMF annual report
In the industry there is lot of confusion about content and format of DMF annual report. Important - DMF annual reports are NOT used for reporting changes in the drug master file. Amendments are used for reporting changes in the DMF. Read More
US FDA Registration is required for your product ? Understanding US FDA Registration Requirements, a complete guide for US FDA compliance.
Manufacturer of Food, Drug and Medical device requires US FDA registration. US FDA Registration is required only if you are planing to market your products in the USA. The term "US FDA registration" or "FDA Registration" is often confused with term "FDA approval". However, FDA approval and registration are two different . .... Read More
US FDA labeling requirements for food
Here is the summary of FDA labeling requirements for food products marketed in the USA.
Overview of US FDA labeli. .... Read More
An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs
FDA requirements for OTC drugs vary for OTC monograph products and new OTC drugs. Drugs with active ingredients published in the OTC final monograph which can be marketed without prior approval from FDA. However, if you are planing to market OTC drugs with active. .... Read More
FDA Drug listing requirements for API (bulk drugs)
Drug establishment registration and drug listing are mandatory requirements for APIs (bulk drugs) commercially marketed in the USA. Manufacturer of API must register their drug establishment where the pro. .... Read More
What is FDA DMF ? US FDA DMF Filing
FDA DMF filing requirements (Drug Master File)DMF stands for Drug Master File which contains confidential information related to the manufacturing, control or chemistry of the product. A US DMF filing is the provision made by the US FDA to maintain the confidentiality of the information in the DMF Filing. The Manufacturer of the Drug, excipient. .... Read More
FDA cosmetic labeling requirements
Overview of FDA requirements for cosmetic labeling.
How are consumer hand sanitizers regulated in the USA ?
Before COVID 19 outbreak most of the hand sanitizers were marketed under the tentative final OTC monograph. On April 12, 2019 FDA issued the final rule, stating only three ingredients namely Ethyl alcohol, Benzalkonium chloride and Isopropyl alcohol are considered under the OTC monograph. As per FDA’s press announcement dated April 11, 2019, “At this time, the. .... Read More
How can FDAbasics help you ? What is the time and cost?
We offer below services to comply with FDA requirements for Hand Sanitizers.
What is FDA’s temporary policy for hand sanitizers?
The FDA’s temporary policy defines several conditions which alcohol based hand sanitizers must follow. FDA defined conditions include the following ;
Who is required to register (Drug Establishment Registration) ?
Drug establishment registration is applicable for manufacturing facilities. Any Establishment engaged in the manufacture, preparation, propagation,compounding, repacking, relabeling, or processing of a drug product for commercial distribution is required to register with FDA. Private label distributors and importers are not required to register. . .... Read More
Who is required to obtain the labeler code ?
Labeler code is a 5 digit number assigned by FDA for each company. Manufacture, Packer and Private label distributor are required to apply for the labeler code for drug listing purpose. . .... Read More
What is the labeler code and drug listing ?
NDC numbers are required on the product label ?
21 CFR 201.2 currently states that NDC’s are "requested but not required" to appear on all drug labels . .... Read More
Who is a private label distributor (PLD) ?
A firm that does not participate in the manufacture or processing of a drug but instead markets and distributes under its own trade name, and labels a drug product made by someone else, is referred to as a Private Label Distributor or PLD.. .... Read More
Is FDA prior inspection required for Hand Sanitizer manufacturing facilities ?
FDA's Temporary policy for hand sanitizers does not mention about the facility inspection. However, manufacturing should be under sanitary conditions. For OTC Hand Sanitizer that does not comply with FDA's temporary policy , manufacturing should be under GMP (Good Manufacturing Practice) conditions , However, prio inspection from FDA is not req. .... Read More
Is there a seperate fee for each pack size listing ?
No, we can cover multiple pack sizes under one fee .. .... Read More
Are surface disinfectants regulated by the FDA ?
No, surface disinfectants are regulated by the EPA.. .... Read More
Does FDA issue certificates upon completion of the successful registration and listing process ?
No, the FDA does not issue the certificate. Registration /listing status can be verified on the FDA website. If required, we can issue the certificate for your confirmation. . .... Read More
Who is required to appoint a US Agent? What are the responsibilities of a US Agent?
It is mandatory for foreign companies to appoint a US Agent for FDA communication purposes. The US Agent acts as a medium of communication between the FDA and the Foreign company. . .... Read More
When a new NDC is required ?
New NDC is required for ;
What information is required for registration and listing ?
For establishment registration- Company Name , DUNS, Physical address, contact person information For drug listing - Proprietary name, Active /inactive names, Information about pack /pack type, representative . .... Read More
How to get FDA approval for Hand Sanitizers
FDA does not approve OTC hand sanitizers, you can sell hand sanitizers by complying with "Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) Guidance for Industry" . You can find an overview of the FDA's temporary policy on our website. FDAbasics can assist you to comply with the below requirements.