Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
New Drug Applications and 505(B)(2) Applications - This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
A newly-published study has compared more than a hundred new drug marketing applications at both the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) in the period 2014-2016. The study examined the...more
Health Canada released proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (“proposed Regulations”) on March 30, 2019. Comments may be submitted until June 8, 2019....more
Please see Chart below for more information....more
On January 4, China’s National People’s Congress (NPC) released draft amendments to the Chinese Patent Law, proposing expanded and enhanced protections that may provide real benefits to companies that develop new drugs. ...more
Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more
Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more