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March 9, 2021

Cannafyl – 611957 – 03/01/2021

Product: Drugs Recipient: Recipient Name Mr. Edward Chaney Cannafyl 7595 E. McDonald Dr., Suite 140Scottsdale, AZ 85250United States [email protected] Issuing Office: Center for Drug Evaluation and […]
March 9, 2021

Marco Antonio Rodriguez Fierro – 610110 – 03/01/2021

Delivery Method: VIA UPS Reference #: 320-21-32 Product: Drugs Recipient: Marco Antonio Rodriguez Fierro Avenida Las Americas 409 Col. Leon Xiii67120 Guadalupe, N.L.Mexico Issuing Office: Center […]
March 9, 2021

Gaza Proveedora De Servicios De Hospedaje Y Alimentacion – 611881 – 03/01/2021

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Mr. Luis Armando Garcia Olivares Recipient Title CEO Gaza Proveedora De Servicios De Hospedaje Y Alimentacion Calle […]
March 9, 2021

Supplement to 10/11/1984 letter about policies, procedures and implementation of the Act (Q&A format)

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This letter provides some information on how FDA intends to implement the Drug Price Competition […]
March 9, 2021

CAMA Wellness Center/IodoRios Company, LLC – 613185 – 03/05/2021

Product: Drugs Recipient: Recipient Name Elise and Max Rivers CAMA Wellness Center/IodoRios Company, LLC 6782 Germantown Ave.Philadelphia, PA 19119United States [email protected] Date:               March 5, 2021 […]
March 8, 2021

Seventh of a series of letters about the Act providing guidance on the “130-day exclusivity” provision of section 505(j)(4)(B)(iv) of the FD&C

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The FDA published Good Guidance Practices in February 1997. This guidance was developed and issued […]
March 8, 2021

Implementation of the Drug Price Competition and Patent Term Restoration Act. Preliminary Guidance

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This letter provides some information on how FDA intends to implement the Drug Price Competition […]
March 8, 2021

Fourth of a series of letters providing informal notice to all affected parties about policy developments and interpretations regarding the Act. Three year exclusivity provisions of Title I

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This is the fourth in a series of letters intended to provide informal notice to […]
March 8, 2021

Fifth of a series of letters providing informal notice about the Act, discussing the statutory mechanism by which ANDA applicants may make modifications in approved drugs where clinical data is required

Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This is another in a series of letters intended to provide informal notice to all […]
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