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Results For "regulatory-affairs"

59 News Found

APhA appoints Ilisa Bernstein Interim CEO
People | June 06, 2022

APhA appoints Ilisa Bernstein Interim CEO

Dr. Bernstein will tap into her decades of leadership and strategy experience as she transitions into this new role at APhA


Susanne Kaestner and Thea Boehm join ProBioGen
People | June 04, 2022

Susanne Kaestner and Thea Boehm join ProBioGen

Susanne Kaestner joins the company as Senior Vice President, Quality and member of the Executive Team, and Dr. Thea Boehm as Vice President, Business Development.


Indian pharma market to grow at a CAGR of 12.3% to US$130 bn
News | June 04, 2022

Indian pharma market to grow at a CAGR of 12.3% to US$130 bn

PharmaLytica Expo to aid in chalking out pharma industry’s $130 Billion growth story by 2030


Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance
People | April 27, 2022

Lupin appoints Diana Amador-Toro as Senior Vice President, Global Compliance

Diana is a senior leader with more than 38 years of field experience in U.S. FDA’s Office of Regulatory Affairs (ORA)


SII’s Covovax approved for 12-17 years age group
News | March 09, 2022

SII’s Covovax approved for 12-17 years age group

The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28th 2021


USFDA issues final guidance on voluntary recalls
News | March 04, 2022

USFDA issues final guidance on voluntary recalls

The guidance also urges companies to act quickly to initiate a recall when public health is at risk and to do so prior to completing an investigation into the cause of the problem


USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy
Biotech | February 25, 2022

USFDA grants Breakthrough Therapy Designation for Idiopathic Pulmonary Fibrosis therapy

Boehringer Ingelheim plans to study this novel investigational therapy in patients with progressive fibrosing interstitial lung diseases


CDSCO recommends EUA for Corbevax in age group 12-18 years
News | February 15, 2022

CDSCO recommends EUA for Corbevax in age group 12-18 years

The recommendation has been sent to the DCGI for approval


Serum receives green light for Omicron variant vaccine
News | February 07, 2022

Serum receives green light for Omicron variant vaccine

Pfizer and Moderna are also working on vaccines that target the Omicron variant


Sauri Gudlavalleti is the new Chief Operating Officer of Sai Life Sciences
People | January 19, 2022

Sauri Gudlavalleti is the new Chief Operating Officer of Sai Life Sciences

He holds nine US patents and has published in multiple peer-reviewed journals and conferences