Containment Generic Drugs Packaging Production 
Camargo
OCTOBER 14, 2021
The expanded use of the INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting : INTERACT meetings are intended to facilitate IND-enabling efforts where a sponsor is facing a novel, challenging issue that might delay the progress of the product towards entry into the clinic in the absence of this early FDA input.
FDA Law Blog
AUGUST 17, 2023
FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). 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. §
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Camargo
DECEMBER 9, 2020
Camargo is currently involved with no less than three product applications that are stalled because the FDA is requiring inspections before the application can be approved (assuming a satisfactory outcome). Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product.
Pharmacy Checkers
MAY 22, 2020
has proved itself to be too dependent on drug imports from China. Although I for one can’t stand China-bashing or any unnecessary nationalistic rhetoric, that doesn’t mean we should be as reliant as we are on China for critical products such as life-saving pharmaceuticals. The Januvia package reads “Formulated in UK.”
Pharma in Brief
AUGUST 9, 2021
On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. Generic drugs and biosimilars are not eligible for this application pathway. Biologic Drugs. On-site Evaluations.
Drug Discovery World
MARCH 29, 2023
Regulatory data protection (RDP) period RDP refers to the time when generic drug makers cannot refer to an innovator drug’s data to obtain a marketing authorisation 2. However, stakeholders should be aware that the leaked review contains no such analysis.
Pharma in Brief
JANUARY 9, 2022
In 2020, the FC struck down the new price calculation contained in the amendments but upheld the other impugned amendments. The proposed amendments contain fee changes including the introduction of an excess claim fee for applications with over 20 claims. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.
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