The World in Brief ( April 2nd Edition)

The World in Brief

This e-newsletter is provided courtesy of Reed CNY Business Law, P.C.


EMPLOYMENT & LABOR – CDC Issued Relaxed Guideline for Employer

The Centers for Disease Control and Prevention (“CDC”) recently significantly relaxed its recommendations for what an employer should do when a worker may have been exposed to someone with COVID-19. Previously, the CDC recommended that any worker having such close contact with an individual with a confirmed or suspected case of COVID-19 be sent home for a period of up to 14 days. The CDC’s updated guidelines states that essential workers who are and remain asymptomatic are now advised that they can return to work so long as they follow additional precautions suggested by the CDC. Reed Business Law provides the most updated guidelines for employers and employees regarding employment & labor issues.

미국질병예방센터는 코로나바이러스에서 완치된 직원들이 회사에 복귀했을 때, 회사의 방침에 대한 업데이트된 가이드라인을 발표했습니다. 본 가이드라인은 기존의 것보다 매우 완화된것으로 기존 가이드라인은 코로나바이러스에 감염이 되었거나 증상이 의심되는 직원들은 반드시 14 일간의 재택근무를 요구했습니다. 반면에, 업데이트된 가이드라인은 무증상의 직원중에서 필수직종에 근무하는 경우, 재택근무대신 직장에서 근무를 할수있도록 완화된 방침을 추천하고 있습니다. Reed Business Law 노동법이슈에 관련한 컨설팅을 근로자, 회사 모두에 제공하고 있습니다.

Related news: https://www.cdc.gov/coronavirus/2019-ncov/community/critical- workers/implementing-safety-practices.html


BIO-PHARMA – FDA Collaboration with U.S. Government Account Office

The U.S. Government Accountability Office (“GAO”) just completed an analysis of 637 new drug applications (NDAs) submitted to the Food and Drug Administration from 2014-2018. The purpose was to determine whether the amount of time to review an NDA differed across the more than 20 divisions (Anesthesia, Anti-infective, Addiction, Dermatology, Gastroenterology, Hematology, Neurology and Oncology, for example), and to identify factors that impacted review periods.

The GAO found most division review periods were within 2 weeks of each other, and the significant factors impacting review periods involved: (1) An ‘expedited pathway’ (Fast Track, Breakthrough Therapy or Accelerated Approval) was involved.

(2) A ‘new molecular entity’ (NME) was involved. (3) A priority review was involved (shortening review period from 10 months to 4 months). (4) A major amendment was submitted (adding 3 months to the review period). Other observations were: (a) The median review time by the Anti-infective division was 2 months faster than the Inborn and Gastroenterology divisions; and (b) after controlling for the four above factors, the Hematology and Oncology divisions were 2-3 weeks faster than the others.


미회계 감사원은 지난 2014 년 부터 2018 년까지 FDA 에 신약개발신청을 한 약품들에 대한 분석을 마쳤습니다. 그 목적은 20 개가 넘는 FDA 부서의 신약개발검사요인과 검사기간을 산정하는 위한 것이었습니다. 조사결과, 대부분의 부서의 신약개발 조사기간은 2 주일내외였고, 조사기간에 크게 영향을 미치는 요인들은 1) 패스트트랙을 결정해야할 시, 2) 신물질신약을 조사해야할 시 3) 우선심사권을 요할시, 그리고 4) 중요사항을 변경할 시등이었습니다. FDA 의 NDA 에 관한 자세한 설명이 필요하시다면, 저희 로펌에 연락주시기 바랍니다.


Related news: https://www.gao.gov/products/GAO-20-244



BIO-PHARMA – Prepare for a Successful FDA Meetings

The most important meeting with any regulatory agency is the meeting BEFORE the meeting. In the pre-meeting the team reviews all of the data one last time, determines who will speak and in what order, and identifies the team’s ‘expert’ for each of the matters likely to be raised by the agency. When our FDA- related clients are too busy to truly commit to the ‘pre-meeting’ process they often find themselves VERY busy after the ‘real’ meeting, putting out the fires that started when they weren’t prepared to deal with the issues the FDA raised during the meeting. Success doesn’t happen at the FDA meeting; it happens at the pre-meetings when we make sure the client is prepared for the FDA meeting.



미국 정부기관과의 미팅을 할 때 가장 중요하게 준비해야할 것은 바로 본미팅전의 준비 미팅입니다. 준비미팅에서 팀원들은 서로가 보유한 데이터들을 마지막으로 한번더 서로 공개해서 어떤 순서대로 미팅시 발표할지에 대해 결정해야합니다. 대부분의 경우에, 저희 클라이언트들은 평소 너무 바쁜나머지 FDA 와의 미팅하기전 미팅에 소홀한 경우가 있습니다. FDA 와의 성공은 미팅당일에 이루어지지않습니다. Reed Business Law 는 클라이언트가 FDA 와 미팅하기전의 미팅에서 철저한 컨설팅을 통해 본미팅의 성공을 보장하고 있습니다.



Related news: https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19- update-daily-roundup-march-30- 2020?utm_campaign=20200401%20MCMi&utm_medium=email&utm_source=Eloqua



US Policies - US To Freeze Exports of Personal Protective Equipment


U.S. Customs and Border Protection (CBP) will hold exports of respirators (including N95 masks), surgical masks and surgical gloves. The Federal Emergency Management Agency (FEMA) will then determine if the equipment should be returned for use in the United States, purchased by the U.S. government or exported. The U.S. Department of Homeland Security claims it has authority to redirect to critical areas up to 50% of the Personal Protective Equipment (“PPE”) entering the U.S. on government flights. Also, 3M Co says it has a separate agreement with the U.S. that will allow it to ship PPE to Canada and Latin America.



미국 정부기관들과 기업들은 현상황의 대처를 위해 여러가지 방안을 발표하고 있습니다. 미 관세 보호청은 모든 인공호흡기 (N95 마스크등), 의료용마스크와 의료용 장갑의 전면적인 수출을 금지했습니다. 재난방지청은 수출된 의료물품들이 미국에 다시 돌아와 쓰여진다면, 미국정부에 의해 구매되도록 결정했습니다. 미 국토안보국은 미국정부소유의 항공기에서 들여오는 개인보호의료장비에 대해 50% 이상의 물품을 재난지역으로 재분배할수 있는 권리가 당국에 있다고 주장했습니다.



Related news: https://www.reuters.com/article/us-health-coronavirus-usa-supplies/u-s-to-seize- exports-of-masks-and-gloves-amid-coronavirus-crisis-idUSKCN21Q30Q




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