We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Zurich, where co-head of Hogan Lovells Life Sciences and Health Care sector Jane Summerfield, and partners Melissa K. Bianchi,...more
On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development and assessment of applications for...more
We were pleased to welcome industry leaders to our Life Sciences and Health Care Horizons event in Boston for the first time since the pandemic. At the event, Hogan Lovells attorneys Eliza Andonova, Ina Brock, Kristin...more
On March 10, 2023, the U.S. Food and Drug Administration (FDA) issued a Notice summarizing which of the agency’s COVID-19-related guidance documents will be rescinded and which will be revised to temporarily remain in effect,...more
Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug industries ability to obtain approvals...more
On July 31, 2019, the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) published a joint report on their efforts to support the development of and expedite access to breakthrough therapies that...more
8/5/2019
/ Biologics ,
Breakthrough Therapy Designation ,
CGMP ,
Data Management ,
European Medicines Agency (EMA) ,
Expedited FDA Approval ,
Food and Drug Administration (FDA) ,
Innovation ,
Manufacturers ,
Regulatory Agencies ,
Regulatory Standards
The U.S. Drug Enforcement Administration (DEA) announced last week that it launched a new tool for its Automated Reports and Consolidated Orders System (ARCOS) Online Reporting System that "will allow DEA-registered...more
On November 9, FDA Commissioner Scott Gottlieb, M.D., announced that the agency launched new inspection protocols for aseptic processing of sterile drugs to be used by FDA investigators during surveillance and pre-approval...more
Last week, the U.S. Food and Drug Administration (FDA) finalized two important Drug Supply Chain Security Act (DSCSA)-related guidances that aim to help pharmaceutical trading partners understand their compliance obligations...more
Earlier yesterday, FDA Commissioner Scott Gottlieb, M.D., made publicly available for the first time FDA’s internal policy (MAPP 5014.1) for how drug manufacturing facilities are prioritized and scheduled for surveillance...more
On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive Manufactured Devices”.
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