Containment FDA Approval Generic Drugs Manufacturing 
Camargo
OCTOBER 14, 2021
The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food.
FDA Law Blog
AUGUST 17, 2023
Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § FDA regulations, at 21 C.F.R. 355(j)(2)(A)(v).
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Camargo
DECEMBER 9, 2020
The August edition of In the News discussed recent FDA guidance detailing the approach to inspections during the COVID-19 pandemic, including the proposed use of various “remote” inspection methods—such as document review—to allow inspections to progress without physical access to the facilities involved. Unapproved Drug Initiative Ends.
Pharmaceutical Technology
JANUARY 6, 2023
In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. Gilenya legal drama.
Pharmacy Checkers
NOVEMBER 21, 2019
The FDA’s capacity to evaluate new and generic drug applications and its oversight over drug manufacturing are why we have this degree of assurance. The FDA is also looked to by drug regulatory authorities in other countries for its strengths. The FDA’s Role in Protecting Our Drug Supply.
XTalks
AUGUST 2, 2023
Most of the company’s revenue comes from the manufacture and sale of biopharmaceutical products. Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. billion in 2022, a 23.43
Pharmaceutical Technology
DECEMBER 4, 2022
While small molecule drugs can be remade into identical generics, biologics are more complex. There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Also, some biosimilars contain citrate, while others like Abrilada do not. It is just a matter of time.”. Free Report.
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