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Consumer Drugs

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FDA OTC Switch Guidance Omits Some Turns As Approval Roadmap, CHPA Says

In its comment on draft guidance, OTC industry trade group urges US FDA to issue final guidance on "Innovative Approaches For Nonprescription Drug Products" in addition to a rule the agency has indicated would soon follow.  CHPA expects that identifying information away not within a Drug Facts label that will be considered in an FDA evaluation would be determined on a case-by-case basis, with a switch NDA sponsor and the agency agreeing to terms of approval during a proposal development and review.

Prescription To OTC Switch Drug Approval Standards United States

Latest From Consumer

Opioid Emergency Clears Supply Chain Security Impediments To Naloxone Distribution

The groups on the front lines of the opioid epidemic may not be physicians or pharmacists or drug wholesalers, but they are the ones that need to receive naloxone if it is to do any good. Latest US FDA guidance removes one of the impediments.

Manufacturing Distribution

After 10 Years, US FDA ‘Additional Conditions’ Proposed Rule Offers ‘Novel Switch’ Pathway

Publication of "ACNU" proposed rule wasn’t reached in a straight line and featured coining another term with a more of a regulatory sound, “NSURE.” The proposed rule also detours on explaining where the agency wouldn’t steer OTC drug manufacturing and marketing.

Prescription To OTC Switch Drug Approval Standards

Expanding US OTC Switches Turns On Flexibility In FDA Drug Approval Process

The “Nonprescription Drug Product with an Additional Condition” for OTC use proposed rule would add to drug firms’ workloads for some OTC switches. Along with NDAs, sponsors would need to show a DFL isn’t sufficient to ensure a consumer can appropriately self-select and use a drug OTC and how an “additional condition” system would work.

Prescription To OTC Switch Drug Approval Standards

US FDA's First-Ever Countrywide Import Alert For Drugs Bans Mexican Hand Sanitizers

Move reflects agency’s growing frustration over deadly methanol adulteration, puts onus on Mexican manufacturers to prove safety and efficacy.

Manufacturing Quality

US FDA Questions Valisure’s Zantac Carcinogenicity Findings

As ranitidine suspensions and recalls mount worldwide, US agency says heat of pharmacy lab's test made nitrosamine levels appear high.

Manufacturing Quality

Court Tosses Amarin Fair Trade Complaint Against Omega-3 Imports

Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.

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