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…publication of the OTC labeling is a lifecycle management tactic that provides a limited period of de facto marketing exclusivity. As Sanofi alleges in the Complaint: Release of Sanofi’s approved…
…(see our blog post here), the regulated community has been eager to engage with FDA to understand both the procedural and substantive requirements for submitting an OTC monograph order request…
…as guidance: Step 2: Give 1st dose of Narcan OTC Nasal Spray HOLD the Narcan OTC Nasal Spray with your thumb on the bottom of the plunger INSERT the tip…
…Horton’s from Canada. On February 28, 2017, Senators Bernie Sanders, Cory Booker, and Bob Casey introduced S. 469, the “Affordable and Safe Prescription Drug Importation Act.” (A companion bill was…
…Medical Board suspended his medical license in 2017). The same doctor was the subject of another frequently cited decision from 2013. This time around, DEA issued an order to show…
…Armando allegedly consumed McNeil’s OTC drug Tylenol Cold (and/or Tylenol Flu) containing pseudoephedrine for a head cold, along with a caffeinated beverage, the morning of the roller hockey game. Doctors…
…an interim order banning the export of certain drugs from Canada. The Final Rule As discussed in our prior post, the Final Rule implements Section 804 of the Federal Food,…
…all are sitting on the sidelines because FDA has not let the OTC rapid antigen tests out of the locker room. Not A Priority FDA’s flawed review approach is compounded…
…the date of publication. Draft Guidance: FDA’s Enforcement Policy The draft guidance document, “Guidance for Industry: Enforcement Policy- OTC Sunscreen Drug Products Marketed Without an Approved Application,” is intended to…
…compliance with this advice could prove difficult. The FDC Act requires that companies maintain records related to reports of any adverse event, whether serious or not, for 6 years. According…
…provide them with an easy way to report it (just dial 877-RX-DDMAC). The program, which begins this month, will be rolled out in three phases: In Phase 1, DDMAC will…
Somewhat later than anticipated, the Federal Trade Commission (“FTC”) has published a revised version of its guide, .Com Disclosures. The FTC released the original guide 13 years ago, when mobile phones…
…ages are common on OTC drug labels. As such, Ms. Sebelius’ claim that cognitive differences between older and younger women requires additional label comprehension studies was found to “reflect[] the…
…kidney injury when OTC products are used at the lower dosages as laxatives.” FDA recommended “that consumers not use OTC OSP products for bowel cleansing,” and promised to amend the…
…by amending OTC drug monographs. In October 2007, FDA’s Nonprescription Drugs and Pediatric Advisory Committees recommended, during a joint committee meeting, a ban on the use of OTC cough/cold drugs…