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The FDA also oversees the development of biological products such as vaccines, products that treat allergies and
cosmetics. FDA regulations govern medical devices, food safety, dietary supplements and cosmetics with the intent
of ensuring those products are accurately labeled and safe to use. The FDA issues recalls for food and other products
that are potentially unsafe.
Guides to the FDA approval processes and guidelines for medical and radiological devicesare available on the
agency's website.
The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of
Health and Human Services, one of the United States federal executive departments. The FDA is responsible for
protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary
supplements, prescription and over-the-counter pharmaceutical
drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic
[4]
radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products. As of 2017, 3/4th of
the FDA budget (approximately $700 million) is funded by the pharmaceutical companies due to the Prescription
Drug User Fee Act.
The FDA was empowered by the United States Congress to enforce the Federal Food, Drug, and Cosmetic Act,
which serves as the primary focus for the Agency; the FDA also enforces other laws, notably Section 361 of the Act
and associated regulations, many of which are not directly related to food or drugs. These include regulating lasers,
cellular phones, condoms and control of disease on products ranging from certain household pets to sperm
donation for assisted reproduction.
The FDA is led by the Commissioner of Food and Drugs, appointed by the President with the advice and consent of
the Senate. The Commissioner reports to the Secretary of Health and Human Services. Scott Gottlieb, M.D. is the
current commissioner, who took over in May 2017.[7]
The FDA has its headquarters in unincorporated White Oak, Maryland.[8] The agency also has 223 field offices and
13 laboratories located throughout the 50 states, the United States Virgin Islands, and Puerto Rico.[3] In 2008, the
FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the
United Kingdom.[9]
The scope of FDA’s regulatory authority is very broad. FDA's responsibilities are closely related to those of several
other government agencies. Often frustrating and confusing for consumers is determining the appropriate regulatory
agency to contact. The following is a list of traditionally-recognized product categories that fall under FDA’s
regulatory jurisdiction; however, this is not an exhaustive list.
Foods, including:
dietary supplements
bottled water
food additives
infant formulas
other food products (although the U.S. Department of Agriculture plays a lead role in regulating aspects of some
meat, poultry, and egg products)
Drugs, including:
prescription drugs (both brand-name and generic)
non-prescription (over-the-counter) drugs
Biologics, including:
vaccines
blood and blood products
cellular and gene therapy products
tissue and tissue products
allergenics
Cosmetics, including:
color additives found in makeup and other personal care products
skin moisturizers and cleansers
nail polish and perfume
The FDA defines itself as the country's oldest consumer protection agency. It traces its origins to the U.S. Patent and
Trademark Office in 1848 and the creation of the U.S. Department of Agriculture in 1862, which carried on the
Patent Office's duties during chemical analyses of agricultural products. The FDA's regulatory functions started with
the 1906 passing of the Pure Food and Drug Act.
As it relates to the healthcare industry, one of the FDA's main goals is to protect the American public from radiation
produced by electronic medical and consumer devices. All products that give off radiation, such as lasers, X-ray
systems and ultrasound equipment, must be preapproved by the FDA's Center for Devices and Radiological Health
(CDRH) before they can go to market. After the CDRH recognizes that a product was safely manufactured, state
agencies supervise the use of that product within their jurisdictions.
The FDA sorts medical devices into three categories according to the stringency of regulation and risk associated
with it. Class I is comprised of low-risk devices, such as many health and wellness wearables, manual wheelchairs
and toothbrushes. The FDA approval process is not applied to 95% of Class I products.
The CDRH has labeled wearable wellness devices used for general health purposes -- such as losing weight,
maintaining physical fitness and measuring sleep -- that present minimal risk to users' safety as Class I. The CDRH
does not plan to impose sanctions on the misuse of any of these products, as they are not intended to treat a specific
condition or disease.
Wellness devices include products primarily for fitness tracking, such as Fitbit and Samsung Gear. The Pebble
Smartwatch, Apple Watch, Withings Activité and other smartwatches also fall under the wellness device category.
The CDRH has also said it generally does not regulate mobile health, or mHealth, apps, but has reserved the
discretion to do so if it deems it necessary.
Class II devices are defined as moderate- to high-risk items. In healthcare, these devices include cardiac output
monitors, wearable body monitoring devices that quantify physical movement for medical purposes, anesthesia kits
and infusion pumps that have increasingly become connected to hospital computer networks. FDA regulations require
most Class II devices to go through a 510(k) premarket notification approval process in which the manufacturer
demonstrates how the device is at least as safe and effective as a legally marketed device.
Manufacturers of Class III devices are required to submit a premarket approval application for the device. Devices in
this class are products or medical equipment that preserve or improve patients' health. Only 10% of all medical
devices fall into this category, including replacement heart valves, breast implants and pacemakers.
ICH GUIDELINES
https://www.slideshare.net/Pradeepben84/ich-9881731
cGMPs:
GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug
Administration under the authority of the Federal Food, Drug, and Cosmetic Act. These regulations, which have the
force of law, require that manufacturers, processors, and packagers of drugs, medical devices, some food, and blood
take proactive steps to ensure that their products are safe, pure, and effective. GMP regulations require a quality
approach to manufacturing, enabling companies to minimize or eliminate instances of contamination, mixups, and
errors. This in turn, protects the consumer from purchasing a product which is not effective or even dangerous.
Failure of firms to comply with GMP regulations can result in very serious consequences including recall, seizure,
fines, and jail time.
GMP regulations address issues including record keeping, personnel qualifications, sanitation, cleanliness, equipment
verification, process validation, and complaint handling. Most GMP requirements are very general and open-ended,
allowing each manufacturer to decide individually how to best implement the necessary controls. This provides much
flexibility, but also requires that the manufacturer interpret the requirements in a manner which makes sense for each
individual business.
GMP is also sometimes referred to as "cGMP". The "c" stands for "current," reminding manufacturers that they must
employ technologies and systems which are up-to-date in order to comply with the regulation. Systems and
equipment used to prevent contamination, mixups, and errors, which may have been "top-of-the-line" 20 years ago,
may be less than adequate by today's standards.
The CGMP requirements were established to be flexible in order to allow each manufacturer to decide individually
how to best implement the necessary controls by using scientifically sound design, processing methods, and testing
procedures. The flexibility in these regulations allows companies to use modern technologies and innovative
approaches to achieve higher quality through continual improvement.
It is important to note that CGMPs are minimum requirements. Many pharmaceutical manufacturers are already
implementing comprehensive, modern quality systems and risk management approaches that exceed these minimum
standards.
If a manufacturer is not following CGMPs, are drug products safe for use
If a company is not complying with CGMP regulations, any drug it makes is considered “adulterated” under the law.
This kind of adulteration means that the drug was not manufactured under conditions that comply with CGMP. It
does not mean that there is necessarily something wrong with the drug.
For consumers currently taking medicines from a company that was not following CGMPs, FDA usually advises
these consumers not to interrupt their drug therapy, which could have serious implications for their health.
Consumers should seek advice from their health care professionals before stopping or changing medications.
Regulatory actions against companies with poor CGMPs are often intended to prevent the possibility of unsafe
and/or ineffective drugs. In rare cases, FDA regulatory action is intended to stop the distribution or manufacturing of
violative product. The impact of CGMP violations depends on the nature of those violations and on the specific drugs
involved. A drug manufactured in violation of CGMP may still meet its labeled specifications, and the risk that the
drug is unsafe or ineffective could be minimal. Thus, FDA’s advice will be specific to the circumstances, and health
care professionals are best able to balance risks and benefits and make the right decision for their patients.
What can FDA do to protect the public when there are CGMP violations?
If the failure to meet CGMPs results in the distribution of a drug that does not offer the benefit as labeled because, for
example, it has too little active ingredient, the company may subsequently recall that product. This protects the public
from further harm by removing these drugs from the market. While FDA cannot force a company to recall a drug,
companies usually will recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn
the public and can seize the drug.
FDA can also bring a seizure or injunction case in court to address CGMP violations even where there is no direct
evidence of a defect affecting the drug’s performance. When FDA brings a seizure case, the agency asks the court for
an order that allows federal officials to take possession of “adulterated” drugs. When FDA brings an injunction case,
FDA asks the court to order a company to stop violating CGMPs. Both seizure and injunction cases often lead to
court orders that require companies to take many steps to correct CGMP violations, which may include repairing
facilities and equipment, improving sanitation and cleanliness, performing additional testing to verify quality, and
improving employee training. FDA can also bring criminal cases because of CGMP violations, seeking fines and jail
time.
How would a new drug company learn about CGMPs and about FDA’s expectations on complying with them?
FDA publishes regulations and guidance documents for industry in the Federal Register. This is how the federal
government notifies the public of what we are doing and why. FDA’s website, www.fda.gov also contains links to the
CGMP regulations, guidance documents, and various resources to help drug companies comply with the law. FDA
also conducts extensive public outreach through presentations at national and international meetings and conferences,
to discuss and explain the CGMP requirements and the latest policy documents.