Instruct: Given a question, retrieve passages that answer the question.
Query: When was the FDA formed?
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, also known as the "Wiley Act" after its chief advocate.[1] The Act prohibited, under penalty of seizure of goods, the interstate transport of food which had been "adulterated," with that term referring to the addition of fillers of reduced "quality or strength," coloring to conceal "damage or inferiority," formulation with additives "injurious to health," or the use of "filthy, decomposed, or putrid" substances. The act applied similar penalties to the interstate marketing of "adulterated" drugs, in which the "standard of strength, quality, or purity" of the active ingredient was not either stated clearly on the label or listed in the United States Pharmacopoeia or the National Formulary. The act also banned "misbranding" of food and drugs.[6] The responsibility for examining food and drugs for such "adulteration" or "misbranding" was given to Wiley's USDA Bureau of Chemistry.[1]
In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration (FDA), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the pre-clinical studies or other supporting evidence, case studies of off label use, etc. are submitted in support of an Investigational New Drug (IND) application to the FDA for review prior to conducting studies that involve even one human and a test article if the results are intended to be submitted to or held for inspection by the FDA at any time in the future (in the case of an already approved test article, if intended to submit or hold for inspection by the FDA in support of a change in labeling or advertising). Where devices are concerned the submission to the FDA would be for an Investigational Device Exemption (IDE) application if the device is a significant risk device or is not in some way exempt from prior submission to the FDA. In addition, clinical research may require Institutional Review Board (IRB) or Research Ethics Board (REB) and possibly other institutional committee reviews, Privacy Board, Conflict of Interest Committee, Radiation Safety Committee, Radioactive Drug Research Committee, etc. approval whether or not the research requires prior submission to the FDA. Clinical research review criteria will depend on which federal regulations the research is subject to (e.g., (Department of Health and Human Services (DHHS) if federally funded, FDA as already discussed) and will depend on which regulations the institutions subscribe to, in addition to any more stringent criteria added by the institution possibly in response to state or local laws/policies or accreditation entity recommendations. This additional layer of review (IRB/REB in particular) is critical to the protection of human subjects especially when you consider that often research subject to the FDA regulation for prior submission is allowed to proceed, by those same FDA regulations, 30 days after submission to the FDA unless specifically notified by the FDA not to initiate the study.
FDA guidelines for companies to follow when recalling defective products under the Agency's jurisdiction are published in Title 21 of the "Code of Federal Regulations", Part 7. These guidelines make clear that FDA expects these firms to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. Under the guidelines, companies are expected to notify FDA when recalls are started, to make progress reports to FDA on recalls, and to undertake recalls when asked to do so by the Agency.
The U.S. Food and Drug Administration (FDA) considers zinc gluconate to be generally recognized as safe (GRAS) when used in accordance with good manufacturing practice, although this does not constitute a finding by the FDA that the substance is a useful dietary supplement. On 16 June 2009 the FDA "warned consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell. ... FDA is concerned that the loss of sense of smell may be permanent." Matrixx responded that the FDA's allegations were "unfounded and misleading", citing a lack of evidence from controlled tests that Zicam causes anosmia. In its warning, the FDA stated, "This warning does not involve oral zinc tablets and lozenges taken by mouth. Dietary zinc is also not subject to this warning." 
Voluntary reporting by healthcare professionals, consumers, and patients is conducted on a single, one-page reporting form (Form FDA 3500). Reporting can be conducted online, by phone 1-800-FDA-1088, or by submitting the MedWatch 3500 form by mail or fax 1-800-FDA-0178. In 2013, MedWatch introduced Form 3500B, which is designed to facilitate reporting by healthcare consumers. The MedWatch system is intended to detect safety hazard signals for medical products. If a signal is detected, the FDA can issue medical product safety alerts or order product recalls, withdrawals, or labeling changes to protect the public health. Important safety information is disseminated to the medical community and the general public via the MedWatch web site. and the MedWatch E-list.
23andMe only sold raw genetic data and ancestry-related results in the US due to FDA restrictions from November 22, 2013 until October 21, 2015, when it announced that it would resume providing health information in the form of carrier status and wellness reports with FDA approval. Wojcicki said they still plan to report on disease risk, subject to future FDA approval.
These test results are both lower and more accurate than a previous long-term study by the FDA. In the Total Diet Study that FDA conducted from 1996 - 2001 to determine the amounts of volatile organic compounds in various foods, FDA used an analytical procedure that caused more benzene to form in the drinks during the test.
The forms presently used to file aseptic processes for low-acid foods with the FDA is Form 2541c. Processes for acidified foods that are aseptically processes and packaged are filed under 2541a. Additionally, processing plants must be registered with the FDA using Form 2541. The FDA has also developed a Low-acid Canned Food (LACF) Electronic Process Filling System that facilitates the completion and submission of the forms.
The header identifies the FDA district office that performed the inspection, the date(s) of inspection, name and address of the facility that was inspected, the name and title of the individual to whom the 483 is issued to (usually the most responsible individual physically present in the facility), a brief description of the type of facility, and the facility's FEI (FDA Establishment Identification) number.
"The observations noted in this Form FDA-483 are not an exhaustive listing of objectionable conditions. Under the law, your firm is responsible for conducting internal self-audits to identify and correct any and all violations of the quality system requirements."
Innovator companies may also present arguments to the FDA that the ANDA should not be accepted by filing a "citizen petition" with the FDA. Citizen petitions are part of the basic law governing everything the FDA does - at any time, any “interested person” can request that the FDA “issue, amend, or revoke a regulation or order,” or “take or refrain from taking any other form of administrative action.” Originally there was no deadline by which the FDA had to respond to citizen petitions filed to protest ANDAs, leading to significant delays in approving generics. In 2007 the law was amended to include a new section, Section 505(q), in the part of the federal code created by the Hatch-Waxman Act; this section said that the FDA could not delay approving an ANDA due to concerns raised in a citizen petition unless the delay was "necessary to protect public health"; it also mandated that the FDA needed to respond to a petition within 180 days - this was shorted to 150 days in a 2011 amendment. In 2014 the FDA issued guidance to industry about submitting citizen petitions and how it would consider them.
Some third parties query the FDA and publish a listing of Form FDA 483s issued since 2000.
Form 483s are available under the Freedom of Information Act, but may be redacted to remove non-public information.
The FDA publishes select 483s on their website at this location:
The trial record shows that the FDA first cleared injectable Phenergan for use in 1955. In 1973 and 1976, Wyeth submitted supplemental new drug applications, which the agency cleared after proposing labeling changes. Wyeth submitted a third supplemental application in 1981 in response to a new FDA rule governing drug labels. Over the next 17 years, Wyeth and the FDA intermittently corresponded about Phenergan's label. The most notable activity occurred in 1987, when the FDA suggested different warnings about the risk of arterial exposure, and in 1988, when Wyeth submitted revised labeling incorporating the proposed changes. The FDA did not respond. Instead, in 1996, it requested from Wyeth the labeling then in use and, without addressing Wyeth's 1988 submission, instructed it to "retain verbiage in [the] current label" regarding intra-arterial injection. After a few further changes to the labeling not related to intra-arterial injection, the FDA cleared Wyeth's 1981 application in 1998, instructing that Phenergan's final printed label "must be identical" to the approved package insert.
Innovator companies may also present arguments to the FDA that the ANDA should not be accepted by filing an FDA citizen petition. Citizen petitions are part of the basic law governing everything the FDA does—at any time, any "interested person" can request that the FDA "issue, amend, or revoke a regulation or order," or "take or refrain from taking any other form of administrative action."[55]
The FDA is responsible for the safety and security of human and animal food and drugs, including any that are genetically modified. The FDA was responsible for approving the first commercialized GMO, Genetech's genetically modified human insulin (Humulin) in 1982 and the first commercialized GM whole food, Calgene's Flavr Savr tomato in 1994. When evaluating new GM foods or feed the FDA looks for the presence of any new or altered allergens and toxicants and examines changes in the levels of nutritional and anti-nutritional substances. Food and feed that is identical or nearly identical in composition to current products is deemed to be substantially equivalent and is not required to undergo review by the FDA. The FDA has been criticized for using substantial equivalence, with a major accusation being that FDA review is essentially voluntary as almost all GM products are substantially equivalent. However, all GM food and feed currently on the US market (as of 2008) have undergone a FDA "consultation", where the developer submits the compositional data and FDA scientist compare it to regular food and feed.
It was first approved in Europe in 1997 and was provisionally approved by the FDA in 1999. In 2001 the FDA issued Pfizer a "not approvable" letter based on clinical trials the FDA had required when it issued the preliminary approval letter.
This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.
Meanwhile, MBPI fell afoul of FDA inspectors and reviewers when it failed inspections (1993, 1997) and received warning letters (1995) and Notices of Intention to Revoke (1997) from the agency. At issue were a failure to validate the AVA manufacturing process to the FDA’s satisfaction and various quality control failures, including reuse of expired vaccine, inadequate testing procedures, and use of lots that had failed testing. All of these developments vexed the Army, not only in its efforts to obtain sufficient vaccine for the troops, but in its desire to have AVA validated and fully licensed for prevention of inhalational anthrax, which is the expected weaponized form of the disease (as opposed to the cutaneous form for which the vaccine had been licensed in 1970). In 1995, the Army contracted with the Science Applications International Corporation (SAIC) to develop a plan to obtain FDA approval for a license amendment for AVA in order to add inhalational anthrax exposure to the product license thus enabling the manufacturer to list on the product license that the vaccine was effective against that form of the disease. The following year, MBPI submitted an "IND application" to modify the product's license to add an indication for inhalation anthrax, thus formally establishing AVA as an "experimental" vaccine when used to prevent anthrax in the inhalational form.
The Angolan Democratic Forum ("Fórum Democrático Angolano") was a political party in Angola. The party was formed by UNITA dissidents in Canada. The chairman of FDA was Jorge Rebelo Pinto Chikoti. The FDA aligned with the Democratic Reflexion Tendency (TRD), which was then not constituted as a formal party. Leaders of TRD included Pablo Tchipilica, Miguel Nzau Puna (former general secretary of UNITA) and Tony da Costa Fernandes.
FDA participated in the 1992 parliamentary election. Many TDR members were on its lists. The party obtained 12,038 votes (0.3%) and one seat in the National Assembly (Miguel Nzau Puna). When Puna was nominated ambassador of Angola in Canada in 1997, his parliament seat was taken over by António Dias da Silva. In 2006, Dias da Silva was expelled from the parliament.
Baricitinib received a CRL from the FDA in April, 2017. The letter indicated that the FDA was unable to approve the application in its current form. Specifically, the FDA indicated that additional clinical data are needed to determine the most appropriate doses and that additional data is necessary to further characterize safety concerns across treatment arms.
This section starts with a "disclaimer" that the form contains the observations of the inspector and does not necessarily "represent a final Agency determination regarding your compliance." Observations placed on a 483 are the opinion of the FDA investigator and may be subject to review by other FDA personnel. The full text is as follows:
In 1987, the United States FDA approved AZT as the first pharmaceutical treatment for AIDS. Around the same time, ACT UP was formed, with one of the group's first goals being to find a way to get access to pharmaceutical drugs to treat HIV. When AZT was made publicly available, it was extremely expensive and unaffordable to all but the most wealthy AIDS patients. The availability of medicine but the lack of access to it sparked large protests around FDA offices.
As of 21-Nov-2009, the FDA is seeking input from the public "on whether inspection reports should be re-designed to separate out a summary or key findings page that could be made available to the public quickly." Responses from the public can be submitted on the FDA's web site.
The U.S. Food and Drug Administration (FDA) is authorized to perform inspections under the Federal Food, Drug, and Cosmetic Act, Sec. 704 (21 USC §374) "Factory Inspection". Form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during these inspections. Also referred to as "Form 483" or merely "483", it states thereon that it