- ... conduct of observational studies at the time of marketing authorization in the form of a postmarketing commitment or ... manner in accordance with the terms of the marketing authorization. The assignment of the patient to a particular ...
- ... basis for global harmonization of pharmaceutical products in marketing authorization applications, labelling, and electronic communications in pharmacovigilance and ...
- ... al 2018 ]. Inotersen is under regulatory review for marketing authorization in the US and EU. Surveillance Serial nerve ...
- NLM Digital Collections - Medical devicesPublication: [Toronto, Ontario] : Thomson Reuters, 23-December-2019... a Breakthrough Device designation and eight have received marketing authorization. These include devices such as the first blood ... FDA's 510(k) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device. ...
- NLM Digital Collections - Interpretation of and compliance policy for certain label requirement : applicability of ...Publication: Silver Spring, MD : Food and Drug Administration, Center for Tobacco Products, March 2019... a tobacco product that is required to have marketing authorization is marketed without authorization, the product is adulterated ... That Modify a Product a. Modifications Outside the Marketing Authorization Order Generally, new tobacco products must obtain premarket ...
- NLM Digital Collections - Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed ...Publication: Silver Spring, MD : Center for Tobacco Products, January 2020... tobacco products that remain on the market without marketing authorization are marketed unlawfully in contravention of the Tobacco ... tobacco product meets the applicable statutory standard for marketing authorization—for example, whether the product is appropriate for ...
- NLM Digital Collections - Developing and responding to deficiencies in accordance with the least burdensome provisions :...Publication: Silver Spring, MD : Center for Devices and Radiological Health, September 29, 2017... made on these applications will be collectively called marketing authorizations (e.g., PMA approval, 510(k) clearance, HDE ... ensure the deficiencies cited are relevant to a marketing authorization decision (e.g., 510(k) clearance, PMA approval, ...
- NLM Digital Collections - Consideration of uncertainty in making benefit-risk determinations in medical device ...Publication: Silver Spring, MD : Center for Devices and Radiological Health, August 30, 2019... not, however, alter the applicable regulatory standards for marketing authorizations.14 FDA describes the guiding principles and approach ... Concept and Principles.15 The Agency generally provides marketing authorization for a device when it meets the applicable ...
- NLM Digital Collections - Deciding when to submit a 510(k) for a change to an existing device : guidance for Industry ...Publication: Silver Spring, MD : Center for Devices and Radiological Health, October 25, 2017... preamendments device or a device that was granted marketing authorization via the De Novo classification process 1 under ... some 1 This guidance applies to devices granted marketing authorization via the De Novo classification process that are ...
- NLM Digital Collections - Evaluation of devices used with regenerative medicine advanced therapiesPublication: Silver Spring, MD : Center for Biologics Evaluation and Research, February 2019... a determination of whether the statutory standards for marketing authorization are met in accordance with the least burdensome ... guidance. When clinical evidence is necessary to support marketing authorization of a medical device, an investigational device exemption ( ...
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