BILLERICA, Mass., December 28, 2020 –Quanterix Corporation(NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, today announced that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its Simoa...
Because this is a prescription test, the specimen is collected at a point of care, usually a doctor’s office, before being sent to a laboratory for testing. Some of the most clinically significant genes that can be identified through the test include: BRCA1 and BRCA2 (a...
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cos...
Authorization Form Textssot__Id__cA unique ID used as primary key for the Authorization Form Text DMO.text Data Sourcessot__DataSourceId__cA reference ID for the logical name for a system that is the source of records identified by external record ID.text ...
for any amendment or supplement to the Form S-4 Registration Statement or Joint Proxy Statement or for any other information and shall supply the other with copies of all correspondence between such party and the SEC or its staff or other governmental officials with respect to the S-4 ...
同意に関連付けられたフォーム (プライバシーポリシーや契約条件など) の特定のバージョンおよび発効日を表します。このオブジェクトは、API バージョン 46.0 以降で使用できます。
if later, the Company met the then-applicable requirements for use of Form S-3 under the Securities Act. During the Agency Period, each time the Company files an annual report on Form 10-K the Company will meet the then-applicable requirements for use of Form S-3 under the Securities Act...
5.These include the use of step edits to discourage doctors from prescribing the more expensive drugs first; or requiring pre-authorization, usually in the form of a specific diagnosis and data on the patient, such as the presence of co-morbidities before dispensing and reimbursing a product. ...
CONFIDENTIAL CONFIDENTIAL Page 3 Page 8 24 June 2020 June 2022 Veklury® Clinical Study Results Remdesivir (RDV; GS-5734™) Study GS-US-540-5773 Interim (Final Part A) Clinical Study Report Final dose administration, as recorded on the Study Drug Administration electronic case report form....
market conditions; the effect of COVID on our business and financial results; obtaining or maintaining regulatory approval, authorization or clearance for our tests; and those factors discussed under the header “Risk Factors” in our ...