Oct 1, 2018 | Drugs, Issue of the Month
By Norma Skolnik, Independent Consultant With the aim of overhauling the regulation of over-the-counter (OTC) monograph drugs, U.S. Senators Johnny Isakson and Bob Casey recently sponsored bipartisan legislation, the Over-the-Counter Drug Safety, Innovation, and...
Oct 1, 2018 | Who’s Who at EAS
This month’s Issue of the Month on Serious Adverse Events Reporting is written by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement industries. Prior to consulting,...
Apr 1, 2018 | Ask the Expert, Drugs
By Norma Skolnik This month’s Ask the Expert question on Serious Adverse Events Reporting is answered by Independent Consultant, Norma Skolnik. Norma has over 35 years of regulatory experience working with the pharmaceutical, OTC drug, and dietary supplement...
Oct 1, 2014 | Issue of the Month
By EAS Senior Consultant, Norma Skolnik Eight new sunscreen active ingredients have been awaiting approval—or any sort of decision—from the FDA for at least 12 years, with the last over-the-counter sunscreen ingredient approved by the agency in the 1990s. Meanwhile,...
Jan 1, 2014 | Issue of the Month
By EAS Senior Consultant Norma Skolnik In 2010 the Natural Resources Defense Council (NRDC) sued FDA to force the agency to issue a final rule on antibacterial soaps. As part of a settlement signed last month, the agency issued a proposed rule Dec. 16, 2013 and...
