US export certificates guidance updates:
This article was originally published in Clinica
Executive Summary
The US FDA has updated its 2002 guidance document on export certificates, which are often demanded by foreign governments to demonstrate that the product being exported can be marketed in the US or meets specific US regulations. The agency has the option of charging a fee of up to $175 if it issues a certificate within 20 government working days of receipt of a complete request for such a document.
You may also be interested in...
Scrip M&A Podcast: Which Companies Could Be Acquired Next?
The editorial team from Scrip discusses the M&A potential of various emerging biopharmas, such as Viking, Verona, Altimmune, Xenon and Crinetics.
New EU Filings
Obecabtagene autoleucel, Autolus Therapeutics’s investigational treatment for relapsed or refractory B cell precursor acute lymphoblastic leukemia, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
P&G Restores Volume Growth In Beauty, Grooming After Pricing Run
Procter & Gamble reports strong consumer spending in the US and Europe after a 3% increase in product pricing over the past year. Dragging on fiscal third-quarter results, sales of SK-II in China fell 30% for the January-March period, while lower incidence of cough and cold impacted Health Care performance.