Speaking at the J.P. Morgan Healthcare Conference this year, Hogan Lovells life sciences regulatory partners Lowell Zeta and Blake Wilson, were joined by Greenleaf Health’s Kalah Auchincloss, Executive Vice President,...more
Despite continued perceived economic headwinds, cutting edge research continues to provide new opportunities for life saving therapies for patients. However, early development programs for advanced medicines using innovative...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
FDA has announced the Advancing Real-World Evidence (RWE) Program, which aims to improve the quality and acceptability of RWE-based approaches that can meet regulatory requirements in support of labeling for effectiveness...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more
Hogan Lovells has teamed up with Demy-Colton to host a special three-part webinar series focused on U.S. market access for life sciences firms, providing companies that are new to the U.S. market, or looking to launch in the...more
On May 19, the U.S. Food and Drug Administration (FDA or the Agency) published the draft guidance “Risk Management Plans to Mitigate the Potential for Drug Shortages,” which aims to assist drug manufacturers in complying with...more
The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a drug’s benefits, risks, and...more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
The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. ...more
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
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
Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more
11/1/2017
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EU ,
Food and Drug Administration (FDA) ,
Inspections ,
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Mutual Recognition Agreement ,
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Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Agencies ,
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Trade Secrets
FDA recently launched a public dashboard within the FDA’s Adverse Event Reporting System (FAERS) to improve access to data on adverse events related to drug and biological products. FDA Commissioner Scott Gottlieb, M.D....more