Drugs Generic Drugs Packaging Regulation 
FDA Law Blog
SEPTEMBER 6, 2023
Farquhar — A drug manufacturer’s bad post-inspection grade from the U.S. Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. By Douglas B.
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. The following is a general summary of some of the highlights from the proposed amendments discussed in the Notice of Intent.
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Pharmaceutical Technology
NOVEMBER 21, 2022
Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.
Pharmaceutical Technology
NOVEMBER 21, 2022
Six companies responded to the OPIR survey by claiming that a lower drug price was the main reason for them to change their strategy in the market while another two companies said that the drug price was the second most important factor for them to change their investment plan.
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).
The Pharma Data
MAY 17, 2021
The authority to change drug labels outside of considerations for new safety information “could encourage third parties, such as academic investigators, insurance companies, and cooperative trial groups, to initiate such changes,” they wrote. .
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. b) Continued changes to the PMPRB.
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