CARES Act Introduces OTC Administrative Order Process
In a previous blog post, we discussed some significant changes to over-the-counter (OTC) product regulations…
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COVID-19 Stimulus Legislation Will Cost OTC Manufacturers
Tucked away in the nearly 900 pages of the Coronavirus Aid, Relief, and Economic Security (CARES)…
New FDA Guidance on OTC Products
Innovative Thinkers: FDA wants YOU FDA just released a very brief (barely three pages of…
Rx-to-OTC Switch: Expanding to the US Over-the-Counter Market
Changing the marketing status of a drug from prescription (Rx) to over-the-counter (OTC), known as…
Regulatory Developments in Ophthalmology: Applying New FDA Guidance, Part One
The global ophthalmic drugs market size was valued at $33.81 billion in 2022 and is…
The Composition and Value of a Portfolio Analysis
One of Premier Consulting’s differentiating offerings is the portfolio analysis, a high-level, integrated evaluation of…
What is 505(b)(2)?
The 505(b)(2) new drug application (NDA) is one of three U.S. Food and Drug Administration...
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DESI Drugs: Potential Targets for Quick Approvals
Drugs that are on the market but are not approved by the FDA are more…
The GRAS Is Not Always Greener: Why GRAS Status Does Not Guarantee Excipient Safety
Many, if not most, 505(b)(2) submissions represent a change to an approved drug, usually involving…
Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies
As the 505(b)(2) expert, Premier Consulting is frequently asked questions about how to get a…
Fixed-Combination Drug Products: Are Phase 2 and 3 Studies Really Necessary?
Many fixed-dose drug-drug combination products arise from an observation that a synergistic effect occurs when…
Quality Metrics – Coming Soon to Your Manufacturing Facility
The Food and Drug Administration (FDA) began requiring drug efficacy, in addition to safety, for…
The 505(b)(2) Approval Pathway Provides Opportunities for Generics Companies Seeking New Revenue Streams
The “cliff” has passed for pharma but has just begun for generics companies that have…