Generic Drugs Packaging Production Regulation 
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. Food and Drugs Act , R.S.C.,
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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World of DTC Marketing
AUGUST 7, 2022
Once limited to a few new treatments, it’s now being applied widely, even to generic drugs and established regimens.?The Andrew Witty, its CEO, had a 2021 pay package worth $18.4 87% of doctors say patients’ conditions have worsened because of red-tape regulations, and 83% worry the patients will suffer prolonged pain.
Pharmaceutical Technology
NOVEMBER 21, 2022
Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.
Pharmaceutical Technology
NOVEMBER 21, 2022
Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.
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. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.
Pharmacy Checkers
JANUARY 10, 2020
For example, when I’m asked if an FDA-approved generic is the exact same as the FDA-approved brand, my answer is often “no.” That response is related to well-made generic drugs – not those discovered as inferior due to fraud or poor manufacturing , which is a serious problem. FDA: PIERRE FABRE MEDICAMENT PRODUCTION.
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