Pharma in Brief
APRIL 25, 2021
As previously reported , the Proposed FDR Amendments were intended to clarify the regulatory requirements under the Abbreviated New Drug Submission (“ ANDS ”) pathway for generic drug products that contain different forms (e.g.,
FDA Law Blog
APRIL 8, 2024
This year’s report noted that CDER’s Drug Product Catalog contains over 140,000 entries, the same amount as OPQ listed in 2022. In a display of the competition within the generic industry that keeps margins low , this total included 118 new drug applications and 956 generic drug applications.
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Camargo
NOVEMBER 11, 2020
The FDA recently issued the guidance “ Referencing Approved Drug Products in ANDA Submissions ,” clarifying the use of the RLD and reference standard (RS) in an ANDA submission and defining which to reference in the basis of the submission. Manager of Regulatory Compliance. Co-Authors: Jenny Fielder. Ken Phelps. President and Founder.
Pharma in Brief
JANUARY 9, 2022
These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. The courts also had a busy year in 2021.
XTalks
AUGUST 30, 2022
The pharmaceutical industry deals with threats such as product liability, cyberthreats, supply chain disruptions, competition from generic drugs and more. Public health and regulatory compliance entities depend on bureaucratic leadership to run effectively. Therefore, strategic intent is vital when making decisions.
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