 FDA to Hold Two-Day Public Meeting on REMS ChallengesThe FDA plans to hold a two-day public meeting in July on the challenges of standardizing and assessing risk evaluation and mitigation strategies (REMS) for drug and biological products — part of a commitment the agency made to drugmakers under the most recent user-fee agreement. Read More
Biosimilar Interchangeability Battle Moves to CaliforniaAll eyes will be on California this week as it joins a growing list of states trying to decide how to regulate the substitution of biosimilar drugs for their more costly brand counterparts. Read More
House Committee Investigates FDA Official’s Sudden DepartureGOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier this month. Read More
$20M Goldman Sachs Investment Highlights Indian Medtech GrowthGoldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market. Read More
U.S. FDA Losing Global Ops Chief AutorDeborah Autor, U.S. Food and Drug Administration deputy commissioner for global regulatory operations and policy, is leaving to join the regulatory policy team at generic drugmaker Mylan. Read More
Actavis Buys Warner Chilcott for $8.5 BillionFollowing weeks of speculation, Actavis said Monday it will acquire Warner Chilcott in an all-stock transaction valued at $8.5 billion. Read More
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$20M Goldman Sachs Investment Highlights Indian Medtech GrowthGoldman Sachs last week announced plans to invest about $20 million in Indian devicemaker BPL Medical Technologies, marking one of the largest medtech investments made to date in an emerging market. Read More
U.S. FDA Losing Global Ops Chief AutorDeborah Autor, U.S. Food and Drug Administration deputy commissioner for global regulatory operations and policy, is leaving to join the regulatory policy team at generic drugmaker Mylan. Read More
Report Points to Steep Four-Year Rise in Device Warning LettersThe FDA has stepped up its inspections of devicemakers over the last four years, resulting in a steep increase in warning letters, a new report finds. Read More
Anvisa Harmonizes Device, IVD GMPsBrazil is streamlining its good manufacturing practice requirements, replacing RDC 59/2000 for medical devices and Ordinance 686/1998 for in vitro diagnostics with a single regulation, RDC 16/2013. Read More
‘Significant Decision’ Clarified in CDRH Appeals GuidancesCDRH Friday released two guidances aimed at clarifying the center’s appeals process and bringing it in line with last summer’s FDA Safety & Innovation Act. Read More
Philippines Revises Registration PolicyThe Philippines has completed the transfer of regulatory authority for medical devices from the Food and Drug Administration to the Center for Device Regulations, Radiation Health and Research. Read More
Biosimilar Interchangeability Battle Moves to CaliforniaAll eyes will be on California this week as it joins a growing list of states trying to decide how to regulate the substitution of biosimilar drugs for their more costly brand counterparts. Read More
House Committee Investigates FDA Official’s Sudden DepartureGOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier this month. Read More
Actavis Buys Warner Chilcott for $8.5 BillionFollowing weeks of speculation, Actavis said Monday it will acquire Warner Chilcott in an all-stock transaction valued at $8.5 billion. Read More
Japanese API Maker Warned for Broad Lack of Quality ControlAsada Milling, a Japanese maker of active pharmaceutical ingredients (API), has been warned by the FDA for a general lack of quality control — and cleanliness — at its facility located in Gunma, Japan. Read More
Judge: Actavis’ Lialda ANDA Infringes Shire’s ‘720 PatentA federal judge handed Shire a victory May 9, ruling that Actavis’ generic version of Lialda, indicated for ulcerative colitis, infringed the company’s ‘720 patent. Read More
Tenth Annual Medical Device Quality Congress
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