Dostoevsky was sentenced to death but the sentence was commuted at the last moment. However, he was arrested in 1849 for belonging to a literary group, the Petrashevsky Circle, that discussed banned books critical of Tsarist Russia. In the mid-1840s he wrote his first novel, Poor Folk, which gained him entry into Saint Petersburg's literary circles. After graduating, he worked as an engineer and briefly enjoyed a lavish lifestyle, translating books to earn extra money. His mother died in 1837 when he was 15, and around the same time, he left school to enter the Nikolayev Military Engineering Institute. īorn in Moscow in 1821, Dostoevsky was introduced to literature at an early age through fairy tales and legends, and through books by Russian and foreign authors. Numerous literary critics rate him as one of the greatest novelists in all of world literature, as many of his works are considered highly influential masterpieces. His 1864 novella, Notes from Underground, is considered to be one of the first works of existentialist literature. His most acclaimed novels include Crime and Punishment (1866), The Idiot (1869), Demons (1872), and The Brothers Karamazov (1880). Dostoevsky's literary works explore the human condition in the troubled political, social, and spiritual atmospheres of 19th-century Russia, and engage with a variety of philosophical and religious themes. Fyódor Mikháylovich Dostoyévskiy, IPA: ( listen) 11 November 1821 – 9 February 1881 ), sometimes transliterated as Dostoyevsky, was a Russian novelist, short story writer, essayist and journalist.
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To bolster the quality of compounded drugs, FDA last year created a new Office of Compounding Quality and Compliance, which is staffed by compounding experts, pharmacists and chemists. This shifted during the pandemic, when the agency increasingly relied on alternative tools to inspect facilities, including testing samples at the border and reviewing information submitted by a request for records under 704(a)(4) of the Federal Food Drug and Cosmetic Act, as noted by an FDA official last fall (RELATED: FDA official says increasing number of enforcement stem from inspection alternatives, Regulatory Focus, 1 November, 2021).įDA used its records request authority to conduct 45 remote regulatory assessments of sites conducting biomedical research for clinical trials. The agency noted that testing samples “proved to be very effective” in identifying that 84% of hand sanitizers imported from Mexico were not compliant with FDA regulations.įDA said prior to 2021, the “vast majority” of warning letters for violations of good manufacturing practices (GMPs) were based on onsite inspections. In other areas, the report said 57% of the drug adulteration warning letters were based on testing samples, 27% relied on an onsite inspection, 13% were based on a records request, and 3% were prompted by a refusal to cooperate with FDA for a records request. Products included topical antiseptics, salt scrubs, nasal antiseptics, herbal oil sprays, mouth rinses and industrial bleach. OCC, in partnership with the Office of Pharmaceutical Quality (OPQ), conducted manufacturing quality reviews for seven COVID-19 emergency use authorizations (EUAs), including monoclonal antibodies.įDA issued 28 warning letters to companies for promoting fraudulent products for treating COVID. The agency issued 15 enforcement discretion decisions to increase supplies of COVID medicines in shortage, including albuterol, oxygen, and propofol. The OCC also oversaw 138 Class I drug products recalls, 800 drug product recalls in Class II and 100 drug product recalls in Class III. The division obtained injunction against two facilities: Premier Pharmacy Lab and Fusion Health and Vitality and issued 26 notice of noncompliance letters and three notices for noncompliance in conducting clinical trials. In total, OCC issued 140 warning letters across compliance divisions and 101 facility inspection classification letters. #J bubble letter chain trial#Among the specific topics addressed in the report include actions taken against makers of poor-quality compounded drugs, reducing the impact of the opioid crisis, enhancing clinical trial oversight, efforts to implement the Drug Supply Chain Security Act (DSCSA), and initiatives to support global collaborations with other regulators. These are some of the areas highlighted in OCC’s latest annual report released 2 May, detailing enforcement activities taken last year. The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021. |
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