Attack on Sunscreens Continues

Posted: 2021-09-16 19:00:00
The Food and Drug Administration (FDA) was required to issue and put into effect a final sunscreen monograph by November 26, 2019. On March 27, 2020, President Donald Trump signed into effect H.R. 748, the "Coronavirus Aid, Relief, and Economic Security Act" (CARES). This bill eliminated the November 2019 requirement. The CARES Act includes legislative reforms that modernize the way over-the-counter (OTC) monograph drugs are regulated in the United States. Under this Act, sunscreens will be considered generally recognized as safe and effective (GRASE), if they meet conditions newly defined by the FDA. In addition, the FDA is required to issue a proposal to revise the sun-screen requirements for GRASE not later than 18 months after enactment and will sunset by the end of the fiscal year 2022. The CARES Act also addresses the requirement for a new drug application (NDA).1-7.

参考サイト PubMed: covid-19


7月 13, 2021 バイオアソシエイツ


以下、サンフランシスコ州立大学(SFSU)生物学部教授のマイケル・A・ゴールドマン博士(Michael A. Goldman)による記事より:今日、コンピューターモデルを使って構造や回復力のシミュレーションを行わずに、橋を架けて、その上を車でゆっくり走るエンジニアはいないだろう。それなのに、なぜ製薬会社は洗練されたシミュレーションを行わずに、動物や人間で薬を試す必要があるのだろうか? 2021年(6月14日~18日)に開催されたPrecision Medicine World…

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