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DRUG REGULATORY AFFAIRS INTERNATIONAL DRUG REGULATORY AFFAIRS INTERNATIONAL BY DR ANTHONY CRASTO

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DRUG REGULATORY AFFAIRS · 2W ago

FDA permits marketing of device to treat diabetic foot ulcers

Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers. Continue reading. December 2...
DRUG REGULATORY AFFAIRS · 3W ago

Biocon Launches KRABEVA® in India, A Biosimilar Bevacizumab for Treating Several Types of Cancer

Originally posted on New Drug Approvals: Biocon Launches KRABEVA® in India,  A Biosimilar Bevacizumab for Treating Several Types of Cancer On November 23, 2017, Biocon India’s premier Biopha...
DRUG REGULATORY AFFAIRS · 3W ago

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response

FDA updates the label of Tasigna to reflect that certain patients with a type of leukemia may be eligible to stop treatment after sustained response Discontinuation in treatment marks a firs...
DRUG REGULATORY AFFAIRS · 3W ago

FDA clears stereotactic radiotherapy system for use in treating breast cancer

FDA clears stereotactic radiotherapy system for use in treating breast cancer Today, the U.S. Food and Drug Administration cleared a new noninvasive stereotactic radiotherapy system intended...
DRUG REGULATORY AFFAIRS · 1M ago

Normal Operating Range (NOR) and Proven Acceptable Range (PAR)

In June of this year, the EMA issued a revision of their earlier Q&A document focused on NORs, PARs, and DSp.(2) First issued in draft form in 2015, this has been revised based on feedback a...
DRUG REGULATORY AFFAIRS · 2M ago

FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues

FDA reaches agreement with automatic external defibrillator manufacturer over quality control issues Company must cease manufacturing until corrective action is taken  U. S. District Judge D...
DRUG REGULATORY AFFAIRS · 2M ago

FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer

  FDA warns companies marketing unproven products, derived from marijuana, that claim to treat or cure cancer As part of the U.S. Food and Drug Administration’s ongoing efforts to protect co...
DRUG REGULATORY AFFAIRS · 2M ago

FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections

  FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections    The U.S. Food and Drug Administration has determined the agency will recognize eight E...
DRUG REGULATORY AFFAIRS · 2M ago

Statement from FDA Commissioner Scott Gottlieb, M.D., on newsteps to advance medical device innovation and help patients gain faster access to beneficial technologies

Statement from FDA Commissioner Scott Gottlieb, M.D., on newsteps to advance medical device innovation and help patients gain faster access to beneficial technologies Enabling patients and p...
DRUG REGULATORY AFFAIRS · 2M ago

FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues

FDA warns Magellan Diagnostics of significant violations of the law as part of investigation into lead testing issues Today the U.S. Food and Drug Administration issued a warning letter to M...