Containment Generic Drugs Manufacturing Packaging 
Pharmacy Checkers
MAY 22, 2020
One of our more popular Ask PharmacyChecker posts is called “ How can I determine where a drug is manufactured? ” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S. has the pharmaceutical ingredients it needs to make drugs that treat people with Covid-19.
Camargo
OCTOBER 14, 2021
The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation. Eligibility for the pilot program has been limited to excipients that 1) have not been previously used in FDA-approved drug products, and 2) do not have an established use in food.
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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. § 355(j)(2)(A)(v). FDA regulations, at 21 C.F.R.
Pharma in Brief
AUGUST 9, 2021
Terms and conditions would be imposed after discussions with the manufacturer and would obligate them to take steps to manage risks and resolve uncertainties. An RMP summarizes the risks of a drug and the pharmacovigilance activities and other measures that a manufacturer puts in place to monitor and manage any identified risks.
Camargo
DECEMBER 9, 2020
Biopharma and manufacturing company Alkermes was recently able to participate in a remote document review for its ALKS 3831 product. The pharma industry has had meetings with the FDA for new drugs, biologics, and devices for decades. GDUFA has changed this picture, at least for complex drug products.
Pharma in Brief
JANUARY 9, 2022
Meanwhile, the Ontario Superior Court released two decisions dismissing claims made by a generic manufacturer under the Ontario and English Statutes of Monopolies , and common law causes of actions. In 2020, the FC struck down the new price calculation contained in the amendments but upheld the other impugned amendments.
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.
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