Pharma Intelligence

Pharma Intelligence
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Pharma Intelligence

 •  January 15

Executive Summary A study to look at the factors that determine the uptake of biosimilars has been launched by the Finnish regulator.

Pharma Intelligence

 •  January 15

Executive Summary US FDA's complete response letters dropped from 41 in 2016 to 30 in 2017; quality issues as share of total letters continued to climb.

Pharma Intelligence

 •  January 15

Executive Summary Cross-contamination problems figure prominently in notices from US and European agencies that were sent to firms in India and other Asian countries. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  January 15

Executive Summary Drug sponsors operating in Canada might be able to get an exemption from a new requirement that as of Jan. 1 required them to start filing certain regulatory activities in the electronic common technical document (eCTD) format

Pharma Intelligence

 •  January 15

Executive Summary As of Jan. 15, sponsors of therapeutic goods in Australia must follow new recall procedures, which have been updated to ensure they are consistent with current regulatory best practice. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  January 14

Executive Summary Tougher regulatory scrutiny by India amid its massive reliance on such raw materials from China is anticipated, but the current Indian inspection action is just 'normal regulatory duties,' a Shanghai-based regulatory officer said. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  January 14

Executive Summary Pharma and device industries had complained that rule is overbroad, violates the First Amendment and would increase company exposure to liability. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  January 11

Executive Summary A new EU guideline explains how manufacturers and importers of investigational medicinal products can comply with the provisions of a 2017 delegated regulation specifying good manufacturing practice requirements and inspection procedures for such products. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  January 10

Executive Summary FDA has issued draft guidance calling for a risk management approach to assigning manufacturing change categories for licensed biological products. It updates a 20-year old version. Request a free trial today! Register for our free email digests:

Pharma Intelligence

 •  January 9

Executive Summary The Tanzanian drug regulator is holding a stakeholder workshop on Jan. 25 to discuss the adoption of various guidelines drafted by medicines experts within the East African Community network. On the list of documents to be discussed is a draft guideline on the registration of biosimilars. Request a free trial today! Register for...