Containment Drugs Generic Drugs Packaging 
Camargo
OCTOBER 14, 2021
The Center for Drug Evaluation and Research (CDER) has announced the rollout of the Novel Excipient Review Pilot Program in Federal Register Vol. The pilot program is the first step in allowing manufacturers to receive a preliminary review of a novel excipient, prior to drug product formulation.
Pharmacy Checkers
MAY 22, 2020
PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. has proved itself to be too dependent on drug imports from China.
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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. Biologic Drugs.
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).
Camargo
DECEMBER 9, 2020
Evergreening Orphan Drugs May Be Over. The Orphan Drug Act of 1983 provides market exclusivity for drugs intended to treat conditions affecting fewer than 200,000 patients in the US. This effectively “evergreens” the product, preventing generic competition. Unapproved Drug Initiative Ends.
Drug Discovery World
MARCH 29, 2023
Politico published a summary of the key propositions outlined in the draft 2 , and DDW’s Multimedia Editor Megan Thomas investigates their intention, and observes how the industry has responded. Key proposals Approved drugs must launch in all EU countries within two years Politico described this as a measure to ensure a level playing field.
Pharma in Brief
JANUARY 9, 2022
In response to the COVID-19 pandemic, in 2020, the Minister of Health signed interim orders designed to streamline the process to authorize the importation or sale of drugs, vaccines, and medical devices used to diagnose, treat, mitigate, or prevent COVID-19. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.
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