March 2019 – FDA News

GENERIC DRUGS – AN OVERVIEW

A generic drug is a medicine created to be the equivalent to an already marketed brand-name drug in dosage form, safety, strength, route of administration, feature, physical characteristics, and intended use. The similarities between generic drug and brand-name medicine helps to demonstrate bio-equivalence, which shows that a generic medicine works in the same way and gives the same clinical benefit as its brand-name type. In other words, generic medicine can be taken as an equal substitute for its brand-name equivalent. FDA Generic Drugs program conduct inspections of manufacturing plants every year and monitor the drug safety after it has been approved and marketed.

Even though generic drugs and brand-name drugs share the same active ingredients, safety, strength, efficiency and the intended use, the trademark laws in the United States do not allow them to have the same look exactly like other drugs which is already on the market.

Cost difference between Generic medicine and Brand-name medicine

Companies that develop new drugs, like other new products are protected by patents that restrict other companies from manufacturing and marketing the same drug. The patent protects the company’s investment in developing the drugs by giving the sole right to market the drug till the patent is in effect. FDA allows certain period of marketing exclusively the brand-name medicine till the patents and marketing exclusive rights expire. After that, it approves the generic version of the same drug. Generic drugs cost less than their brand-name equivalent because they do not need to repeat animal and clinical studies that were required for brand-name drugs to demonstrate its safety and efficiency. This is also known as “abbreviated new drug application.” The competition between the brand-name drug and multiple generic drugs is the main reason for low-cost generic drug.

Demonstration of ANDA

ANDA must demonstrate the generic medicine is equivalent to its brand-name counter part by the following ways.

Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.
Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.
Treat the same medical condition.
Be absorbed into the bloodstream at a similar rate and over the same period of time.
Meet the same requirements for identity, strength, purity and quality.
Be manufactured under the same strict standards that FDA demands of brand-name drugs.

FDA will make sure that the medicines both generics and brand- name sold in the United States are safe and effective by conducting testing in its laboratories or through research contract and grants. Also FDA encourages physicians and consumers to notify FDA of any adverse side effects when using the drugs and medical devices which FDA regulates by reporting them at MedWatch .

Liberty Management Group , a leading FDA consulting firm in the United States provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consutltant

Mail : office@libertymanagement.us

http://www.fdahelp.us

CERTIFICATE TO FOREIGN GOVERNMENT (CFG)

Certificate to Foreign Government (CFG) is document prepared by FDA issued for legally marketed devices in the U.S that are in compliance with the regulations of FD&C act.

Medical devices that are legally marketed in the United States can be exported to anywhere in the world without getting approval from FDA. Although FDA does not restrict the export of legally marketed, certain importing countries require a certification from FDA stating that the firm, or its devices are in compliance with U.S. FDA regulations. Foreign government will ask for official assurance that the products exported to their countries are in compliance with US FDA regulations such Good manufacturing Practice (GMP) requirements. In that cases, U.S companies can request a certificate to foreign government (CFG) also known as Certificate of Free sale to FDA.

The certificate to foreign government (CFG) 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 being exported from the U.S.

Requirements to get the Certificate to Foreign Government (CFG)

The manufacturing facility must have a valid medical device establishment registration
All devices must be listed with 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.

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

The fees for export certificate from CDRH is $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

Mail : office@libertymanagement.us

http://www.fdahelp.us

OVER-THE-COUNTER (OTC) DRUG PRODUCTS

Over-the-Counter drugs (OTC) also known as nonprescription drugs are medications sold directly to consumers without a prescription from a physician. OTC drugs are in general considered as safe and effective for use by the consumers without getting treatment from a healthcare professional. There are more than 300,000 OTC drugs are marketed with about 800 active ingredients.

Although there are more than 80 therapeutic categories of OTC drugs, starting from acne products to weight management drugs, FDA is not approving OTC products, but Center of Drug Evaluation and Research (CDER) ensures that OTC drugs are properly labeled and its ingredients listings. For each category, FDA developed an OTC drug monograph and published in the Federal Register. OTC drug monograph provided guidance which covers doses, acceptable ingredients, formulations and labelling requirements. When the company adheres to OTC monograph, it can make and market an OTC drugs without FDA’s pre-approval. OTC monographs defines the safety, efficiency and labeling of all OTC active ingredients. The drugs for which the active ingredients is not OTC monograph, has to apply for New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

FD&C acts requires firms that manufacture, contract manufacture, repack or re-label or salvaging of OTC drugs in the United States or that are offered for import in the U.S are required to register with FDA and renew their registration annually. Also domestic and foreign establishments must list all drugs that they manufactured, prepared, propagated, compounded, or processed for commercial distribution in the U.S. Foreign firms are required to identify a U.S agent and importers at the time of registration.

FDA Drug establishment registration needs to be submitted electronically using Extensible Markup Language (XML) files in the Structured Product Labeling (SPL) format. The firms must use FDA’s Electronic Submission Gateway (ESG) to submit SPL files.

Private Label Distributors (PLD) are not required to register their establishment with FDA, however they have to apply for their own Labeler code and list their drugs with FDA. FDA has a released a list of summary of registration and listings requirements for the manufacture or distribution of human pharmaceuticals, which can be seen at https://www.fdahelp.us/Pdf/Drug.pdf

Drug establishments that are registered with FDA must list all the products they manufacture for commercial distribution under their own labeler code, which includes the API manufacturers, bulk manufacturers, contract manufacturers, re-packers and re-labelers.

FDA has published a regulation establishing standardized content and format for the labeling of OTC drug products (Drug Facts labeling). The Drug Facts labeling for OTC drug products is intended to make it easier for consumers to read and understand OTC drug product labeling and use OTC drug products safely and effectively. All drugs or drug products in finished package form is considered as misbranded if it does not comply with FDA labeling requirements.

Liberty Management Group provides assistance with drug establishment registration, drug listing and label review.

Sudha S

Regulatory Consultant

Mail: office@libertymanagement.us

http://www.fdahelp.us

UNIQUE DEVICE IDENTIFICATION (UDI)

FDA has released a final rule under which all medical devices will be marked with a Unique Device Identifier (UDI) that will appear on the label and package of a device which is used to identify the devices through their distribution and usage of it. UDIs should be on the device labels in both a human-readable format and a machine-readable format (e.g., a barcode) unless the rule provides for an exception or alternative. The UDI should be marked directly on the devices that are intended for more than one use and has to be reprocessed before each use.

A UDI consists two parts, Device Identifier (DI) and Product Identifier (PI), where

Device Identifier (DI) is a mandatory, fixed portion of a UDI which identifies the specific version or model of a device and its labeler. Labeler has to apply for New DI if there is any change in version or model of the device.

Product Identifier (PI) which is a conditional and variable portion of a UDI is required to identify the lot or batch number of a specific device , serial number, expiration date, date of manufacture and the distinct identification code(If applicable). PI will change for each lot or batch.

FDA has accredited the following agencies in assignment of UDIs according to the UDI regulations.

GSI – http://www.gs1.org /
Health Industry Business Communications Council (HIBCC) – http://www.hibcc.org /
International Council for Commonality in Blood Banking Automation (ICCBBA – http://www.iccbba.org

Each issuing agency has a unique device identifier (UDI) format that was assessed and approved by FDA as part of its process for accrediting issuing agencies. Any changes to the format of the UDI by an issuing agency must be approved by FDA before implementation.

Device labelers are required to submit information about each device to FDA’s Global Unique Device Identification Database (GUDID), where the public can search and download information from GUDID at AccessGUDID. GUDID has a standard set of basic elements for each device with a UDI, which contains only DI that helps to get the device information in the database. Product Identifiers (PI) are not part of GUDID

Compliance Dates issued by FDA in conjunction with UDI Final Rule are

Class III medical devices which includes stand –alone software – September 24, 2014
Implantable, life supporting and life sustaining devices which includes stand-along software – September 24, 2015
Class III reusable devices that are required to have UDI on the device itself, Class II devices – September 24, 2016
Class II reusable devices that are required to have UDI on the device itself, Class I which includes stand-alone software and Unclassified devices – September 24, 2018
Class I reusable devices that are required to have UDI on the device itself – September 24, 2020
For Class I and unclassified devices manufactured and labeled on or after September 24, 2018 – September 24, 2022
For Finished Class I and unclassified devices manufactured and labeled before September 24, 2018 – September 24 , 2022

Liberty Management Group, a leading FDA consulting group in the United States, provides assistance with UDI account creation, selection of Accrediting agency, GUDID submission.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us