FDA approval process and FDA Certification What is the FDA approval process or FDA certification? The answer to this question depends on your product category. Here are the FDA approval requirements for each category of products i.e., Food, Drug, Medical Device, and Cosmetics. What is FDA certification? There is no such process or … Continue reading FDA approval process and FDA certification
FDA approval for hand sanitizer – FDA approval is not required for OTC hand sanitizers. If you are planning to market Alcohol or Benzalkonium based hand sanitizer, you have to comply with FDA requirements for hand sanitizer listed below. Drug establishment registration US Agent appointment (for foreign companies) Obtain a labeler code Drug listing Compliance … Continue reading FDA hand sanitizer registration, FDA requirements for hand sanitizer or FDA approval for hand sanitizer ; What is required?
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 … Continue reading How to get FDA approval for Hand Sanitizers
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 image of the product label and name and DUNS number of the manufacturer.
New NDC is required for ; New strength or new active ingredient New Dosage form Any change in physical appearance (size, shape, color, scoring, imprint, etc.) Changes to inactive ingredients Change in proprietary name
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.
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.
No, surface disinfectants are regulated by the EPA.
No, we can cover multiple pack sizes under one fee .
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 required, FDA may inspect your … Continue reading Is FDA prior inspection required for Hand Sanitizer manufacturing facilities ?
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.
21 CFR 201.2 currently states that NDC’s are “requested but not required” to appear on all drug labels
You can find more information about https://www.fdabasics.com/our-faq/ndc-number/
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.
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.
The FDA’s temporary policy defines several conditions which alcohol based hand sanitizers must follow. FDA defined conditions include the following ; Quality and source of alcohol Active and inactive composition Product composition Testing requirements Labeling requirement Manufacturing in sanitized condition with well maintained equipment Establishment registration and drug listing Specific dosage form (liquid only) … Continue reading What is FDA’s temporary policy for hand sanitizers?
We offer below services to comply with FDA requirements for Hand Sanitizers. US Agent services– Appointment of US Agent is mandatory for foreign companies. Our fee for US Agent services is $ 299 per year. You can complete an online form at the link below and make the payment. After receipt of the completed form … Continue reading How can FDAbasics help you ? What is the time and cost?
FDA regulation for hand sanitizers finalized the FDA’s previous determination that 28 active ingredients, including triclosan and benzethonium chloride, are not eligible for review under the FDA’s OTC Drug monograph system. FDA regulation for hand sanitizers reaffirms the requirement of additional safety and efficacy data on three other active ingredients (benzalkonium chloride, ethyl alcohol, … Continue reading FDA regulation for hand sanitizers. How are consumer hand sanitizers regulated in the USA ?
Overview of FDA cosmetic labeling requirements Here is a list of FDA cosmetic labeling requirements The common name of the product must be displayed prominently on the principal display panel. Example “Moisturizing cream” New weight should appear prominently on the PDP Cosmetic Ingredient labeling; all the ingredients used (except flavors and fragrances) must appear … Continue reading FDA cosmetic labeling requirements FDAbasics
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, … Continue reading What is FDA DMF ? US FDA DMF Filing
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 product is manufactured, packed or processed and list all the drugs which are in the commercial distribution. What information is required for API drug listing ? Below … Continue reading FDA Drug listing requirements for API (bulk 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 ingredients which are not part of the OTC monograph you should … Continue reading An Overview of FDA Requirements for OTC Drugs (Over the Counter Products ) and understanding FDA regulation for OTC drugs
Here is the summary of FDA labeling requirements for food products marketed in the USA. Overview of US FDA labeling requirements for food The product should bear a statement of identity (common name of the product) more prominently on the principal display panel. Net weight should appear both in US customary and metric systems ( … Continue reading US FDA labeling requirements for food
Manufacturer of Food, Drug, and Medical device requires US FDA registration for their facilities. US FDA Registration is only needed if you are planning to market your products in the USA. FDA registration vs. FDA approval The term “US FDA registration” or “FDA Registration” is often confused with the term “FDA approval.” However, FDA … Continue reading US FDA Registration is required for your product ? Understanding US FDA Registration Requirements, a complete guide for US FDA compliance.
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. Contents of DMF annual report. 1.Cover letter – Annual report should contain the formal … Continue reading What should you know about DMF annual report
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 instructions to search FDA Registration Number 1. Food Facility … Continue reading How to search FDA registration number
FDA registration renewal timelines? The answer to this question depends on whether your product is Food, Medical Device, or Drug. Food facility registration renewal Food facility registration must be renewed every even year between 1st October to 31st Decemebr. For example, in 2018, 2020, and 2022. We offer free assistance for food facility registration … Continue reading How to Renew FDA Registration – Timelines and Fees
Electronic Common Technical Document -eCTD eCTD 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 requirements. Contents of e-CTD ICH recommended CTD folder structure XML backbone containing metadata such as document id, document version, hyperlinks, … Continue reading eCTD Requirements and cost effective solutions
In order to market food products in the United States, you must first comply with the following requirements: Appoint a US Agent (for all foreign companies) Establishment Registration Labelling GMP manufacturing Prior import notice Please click here for detailed information. Pragmatic Compliance LLC can offer you all the guidance to help you market your food … Continue reading How can I market food products?
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. When is an FSVP Agent or FSVP Importer is required ? An FSVP Agent is required when there is no U.S. owner … Continue reading FSVP Agent (FSVP Importer) – FSVP requirements
When is the FDA Biennial Registration Renewal period for Food Facility? Food facility registration must be renewed every even 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 … Continue reading FDA Biennial Registration Renewal period Food Facility
FSVP stands for the Foreign Supplier Verification Program. FSVP is one of the requirements as per the FSMA rule, which requires importers in the United States to verify their foreign suppliers to ensure their suppliers follow food safety standards equivalent to the standards established by the FDA. As per the FDA’s FSMA rule, foreign … Continue reading What is FSVP ?
FDA requirements for food 1. Food Facility Registration Food facility registration is one of the FDA requirements for food products. If you are a foreign company or importing food products manufactured in foreign country, then such foreign facilities are required to appoint U.S Agent and register the facility. Pragmatic Compliance LLC shall act as U.S … Continue reading What are the FDA requirements for food
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.
After you have provided the required information, it takes about 48 hours to complete the food facility registration.
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.
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 … Continue reading How much is the DMF Fee ?
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 … Continue reading How much time is required for DMF submission?
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.
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.
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, … Continue reading Our Services for GDUFA Self Identification Requirement
Below are the basic responsibilities of US Agent. Acting as an intermediary for communications between the FDA and foreign companies. Provides assistance to answer any questions concerning the foreign establishment’s devices that are imported or offered for import into the United States Assists the FDA to schedule inspections of the foreign establishments Acts as a representative … Continue reading Responsibilities of US Agent
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. For food and dietary supplements companies, US Agent fees are … Continue reading How much is the US Agent fee?
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 to sign our US Agent contract. If you are a drug … Continue reading How much time will it take to appoint 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.
No. Our fees are transparent and there are not hidden charges.
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.
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.
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 applicable to … Continue reading What are the requirements for marketing medical devices in the United States?
Pragmatic supports companies to classify their medical devices and identify the applicable regulatory requirements. Our complete solution takes through each stage of the requirements.
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.
With our support, the self-identification process takes about 48 hours.
The FDA publishes a list of all self-identified facility addresses, along with their type of business.
Basic contact information is required, along with information about the nature of the operations – for example, FDF manufacturing or API manufacturing testing.
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.
All facilities involved in generic drug manufacturing (including API manufacturing), packing, testing and bio-equivalence testing are required to self-identify.
Our fees for drug listing are $250.
Our fees for NDC number assistance are $199.
For drug listing, we need the following information: Product label Labelling information Packaging configuration FEI number
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.
Once we have the information, the process takes two to three days.
This process takes around 48 hours.
The owner or operator of an establishment entering into drug manufacture or preparation.
What is an NDC Number (National Drug Code) and Drug Listing? NDC number is a ten-digit numerical code assigned to drugs. The first five digits of the NDC come from the labeler code. The FDA assigns labeler code to the manufacturer, distributor, or private label distributor of the product. The first step for the NDC … Continue reading What Is an NDC Number? FDAbasics.com – Drug Listing
Drug listing is the process of providing product and labeling information to FDA in electronic format.
What is an NDC labeler code, and how to get it? NDC Labeler Code is a five-digit number assigned by the FDA to firms intended to market/manufacture the drug. Labeler code constitutes the first five digits of the NDC number. After obtaining an NDC labeler code from the FDA, the firm can submit the … Continue reading What is an NDC labeler code? FDAbasics
Establishments must renew their registration annually, between October 1st and December 31st of each year.
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.
The FDA does not charge any fee for Establishment Registration. See our pricing section for consulting fees.
Generally, it takes two to three working days.
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
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.
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.
If all the submitted information is appropriate and correct, the process takes between 12 and 16 months. If you have any other questions about ANDA, please feel to contact us.
ANDA fee for FY 2019 are as below. ANDA fee – $ 178,799 . This fee is applicable for each ANDA. ANDA Program fee – This is the annual for ANDA holder. Large Size $ 1,862,167 Medium Size $ 744,867 Small Size $ 186,217 Large: 20 or more approved ANDAs; Medium: between … Continue reading How much is ANDA fee?
Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.
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.
Any companies interested in obtaining generic drug approval should file ANDA.
ANDA is the Abbreviated New Drug Application, the FDA’s generic drug approval process.