Generic Drugs Packaging Regulation 
FDA Law Blog
SEPTEMBER 6, 2023
As predicted in an earlier blogpost , FDA last week released a draft guidance that provides a pathway for generic drug manufacturers to secure a meeting with FDA so that affected companies can get answers to their questions in these circumstances.
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.
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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.
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). patients in harm’s way.”
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.
The Pharma Data
MAY 17, 2021
These initiatives could support insurance coverage of previously off-label uses, prevent costly new drugs from inappropriately receiving preferential regulatory treatment that is intended for drugs with no FDA-approved alternatives, and better inform clinicians by providing evidence-based information about how drugs should be used,” they noted. .
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.
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