about the author

Michael Mezher

mmezher@raps.org

Michael Mezher is a news editor for RAPS’ Regulatory Focus, the flagship publication for the largest organization of and for those involved with the regulation of health products. He has covered drug and medical device regulation for Regulatory Focus since 2015.

author articles

FDA is­sues new rec­om­men­da­tions to take on Covid-19 vari­ants

4 years ago
FDA+

In­spec­tions: GAO calls on FDA to plan for back­log, re­view al­ter­na­tives

4 years ago
FDA+

CDER lays out 2021 guid­ance agen­da

4 years ago
FDA+

Biden in­sti­tutes reg­u­la­to­ry freeze on first day of pres­i­den­cy

4 years ago
FDA+

HHS, FDA dis­pute spills out on­to Twit­ter

4 years ago
FDA+

PDU­FA VII: FDA and in­dus­try set pri­or­i­ties in first round of ne­go­ti­a­tions

5 years ago
FDA+

FDA of­fi­cials, ex­perts dis­cuss im­pact of Covid-19 on cell and gene ther­a­pies

5 years ago
Cell/Gene Tx
FDA+

Hahn in­sists FDA will stick to guide­lines for Covid-19 vac­cine de­ci­sions

5 years ago
FDA+
Coronavirus

FDA re­leas­es PDU­FA VI pro­gram re­port on com­bi­na­tion prod­ucts

5 years ago
FDA+

FDA drafts rec­om­men­da­tions for study­ing can­cer drugs in pa­tients with CNS metas­tases

5 years ago
FDA+

PDU­FA VII: FDA, in­dus­try pre­view their reau­tho­riza­tion wish lists

5 years ago
FDA+

House com­mit­tee ad­vances bills aimed at or­phan ex­clu­siv­i­ty, gener­ic la­bel­ing and con­tin­u­ous man­u­fac­tur­ing

5 years ago
FDA+

Ex­perts urge trans­paren­cy, ad­vi­so­ry com­mit­tee re­view for Covid-19 vac­cines

5 years ago
FDA+
Coronavirus

Pe­ter Marks on Covid-19 vac­cine ef­fi­ca­cy, EUAs and chal­lenge tri­als

5 years ago
FDA+
Coronavirus

EMA nom­i­nates Emer Cooke as ex­ec­u­tive di­rec­tor to re­place Gui­do Rasi

5 years ago
People

Hahn tes­ti­fies on Covid-19 re­sponse, says FDA on tar­get to hit user fee goals

5 years ago
FDA+
Coronavirus

FDA of­fers sta­tis­ti­cal guid­ance for tri­als im­pact­ed by Covid-19

5 years ago
FDA+
Coronavirus

FDA warns Take­da over asep­tic pro­cess­ing, in­ad­e­quate in­ves­ti­ga­tions

5 years ago
FDA+

Pe­ter Marks dish­es on Covid-19 vac­cine de­vel­op­ment at BIO

5 years ago
FDA+
Coronavirus

FDA de­fends its over­sight of for­eign drugs amid Sen­ate, GAO crit­i­cism

5 years ago
FDA+

Stephen Hahn: FDA will make some changes amid Covid-19 per­ma­nent

5 years ago
FDA+
Coronavirus

FDA ex­plains im­pact of Covid-19 on ap­pli­ca­tions, for­mal meet­ings

5 years ago
FDA+
Coronavirus

EMA ex­tends vir­tu­al-on­ly meet­ing pol­i­cy through Au­gust

5 years ago
FDA+
Coronavirus

FDA, Ae­tion part­ner on re­al-world da­ta an­a­lyt­ics for Covid-19

5 years ago
FDA+
Coronavirus
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