Uncategorized – FDA News

SELF-IDENTIFICATION

The FDA Self-Identification applies to facilities and organizations involved in the development and manufacturing of generic drugs.

Facilities that manufacture or intend to manufacture must submit Self-Identification.

Active Pharmaceutical Ingredients (API) of human generic drugs.
Finished Dosage Forms (FDF) of human generic drugs.
Sites and organizations involved in:
Bioequivalence (BE)/bioavailability (BA) sites that are registered as a generic drug submission and conduct clinical BE/BA testing, bioanalytical testing of samples collected from clinical BE/BA testing, and/or in vitro BE testing)
Testing, repackaging, or relabeling of generic drugs (exempt from user fees)

Self-Identification must be submitted via CDER Direct or ESG portal by generating SPL files.

Under GDUFA, if a facility fails to self-identify, all FDF or API products manufactured at the facility and all FDFs containing APIs manufactured at the facility will be deemed misbranded. It is a violation of federal law to ship misbranded products in interstate commerce or to import them into the United States. Such violations can result in prosecution of those responsible, injunctions, or seizures of misbranded products. Products are considered as misbranded because of failure of the facility to self-identify are subject to being denied entry into the United States.

Self-identification must be submitted between May 1 and June 1 of each year.

Liberty Management Group LTD, as a leading FDA consulting firm provides assistance with SPL preparation and submission of Self-Identification to FDA.

Sudha S

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

CERTIFICATE TO FOREIGN GOVERNMENT (CFG) – NE (Certificates to Foreign Government for Device Not Exported from the United States.)

Certificates to Foreign Government for Device Not Exported from the United States (CFG-NE) is document issued by FDA issued for legally marketed devices in the U.S that are manufactured by the companies located outside of the United States and are in compliance with the regulations of FD&C act.

Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE) is a self-certification process. By completing the required form, a firm confirms that it is registered with FDA and listed their device with FDA, that each product is legally marketed in the U.S. and is not the subject of an open recall, that all facilities involved in the manufacturing process are complying with the FDA’s regulations, and that each product is not being exported from the U.S.

Requirements to get the Certificates to Foreign Government for Device Not Exported from the United States (CFG – NE)

The manufacturing facility must have a valid medical device establishment registration and must be located outside of the United States.
All devices must be listed with the FDA.
The devices must have cleared Premarket notification (510K) or Premarket Approval (PMA) unless it is exempted by the regulation.
The device should meet all the medical device labelling requirements as of 21 CFR 801 and 809.
The device should be manufactured in accordance with 21CFR 820 also known as Good Manufacturing practice unless it is exempted by the regulation.
Each device(s) identified is not the subject of an import alert, recall, seizure, injunction, or the subject of any other FDA enforcement action.
Manufacturers, contract manufacturers, and contract sterilizers involved in the manufacturing process, if applicable, have been identified

Certificate to Foreign government can be requested through CECATS system. It is a voluntary electronic system that allows the manufacturers to request export documents online. CECATS can be accessed by logging into the FDA Furls account.

The fees for export certificate from CDRH are $175 for the first certificate and $85 each for additional certificate upon the request from the customer.

Liberty Management Group, a leading FDA consulting firm provides assistance with FDA Medical device registration, device listing and certificate to foreign government application.

Sudha S

Regulatory Consultant

Email : office@libertymanagement.us

www.fdahelp.us

REGISTRATION DE-ACTIVATION

The consequences of not renewing US FDA registration can be significant, depending on the type of facility that operates and the products they manufacture.

Food facilities:

Expired registration: If your registration expires, the FDA will consider it a violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Seizure of products: The FDA may seize the products if they believe that the products are manufactured in an unregistered facility or pose a public health risk.

Injunctions: The FDA may seek a court order to prevent from continuing to operate your facility until you come into compliance.

Loss of business: Potential customers and suppliers may be hesitant to do business with a facility that is not in good standing with the FDA.

Medical device establishments:

Expired registration: Like food facilities, an expired registration for a medical device establishment is a violation of the FD&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for medical devices manufactured in unregistered establishments.

Import restrictions: The FDA may restrict the import of medical devices manufactured in unregistered establishments.

Drugs

Expired registration: Like other registration, an expired registration for drug establishments is also violation of FDA&C Act and can lead to:

Warning letters: The FDA may issue a warning letter outlining the violation and requesting corrective action.

Refusal to approve marketing applications: The FDA may refuse to approve marketing applications for drugs manufactured in unregistered establishments. They will consider the drug as misbranded and de-activate all the drugs listed FDA.

Import restrictions: The FDA may restrict the import of drugs manufactured in unregistered establishments. Also, they may seize the products if they believe they are manufactured in an unregistered facility or pose a public health risk.

Liberty Management Group, as a renowned FDA consulting firm can help the companies in renewing the food establishment, drug establishment and medical device establishments in a timely manner.

Sudha

Regulatory Consultant

Email: office@libertymanagement.us

www.fdahelp.us

BLANKET LISTING SUBMISSION

The FDA (U.S. Food and Drug Administration) requires drug manufacturers to submit a “blanket listing submission” for all drug products they manufacture. This listing includes information about the drug products and the facilities where they are manufactured.

A blanket listing submission is a process by which pharmaceutical companies provide the FDA with a comprehensive list of all drug products they manufacture. This includes prescription and over-the-counter drugs.

FDA uses this information to monitor and regulate drug products in the United States. It helps the FDA track the availability and safety of drug products, as well as identify manufacturing facilities and labeler codes associated with these products.

Drug manufacturers must submit/update listing every year between October 1^st and December 31^st even if no changes have occurred.

The submission typically includes detailed information about each drug product, such as its proprietary name, active ingredients, dosage form, route of administration, and National Drug Code (NDC) number. It also includes details about the manufacturing facilities and labeling information.

The FDA now requires electronic submission of these listings through the FDA’s Electronic Submissions Gateway (ESG) in Structured Product Labeling (SPL) format.

Failure to submit or update these listings as required can lead to regulatory action, which includes misbranding and warning letters.

Liberty Management Group Ltd, provides assistance with drugs establishment registration , NDC labeler code request, Drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

office@libertymanagement.us