International Recognition Procedure
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NeoCubes Pharma LLP and Pyxis Pharma s.r.o. Form Strategic Association Through Neocubes Pharma SRO to Enhance Global Pharmaceutical Market Access
Under the Generic Drug User Fee Amendments (GDUFA), facility readiness and goal date decisions are key components of the regulatory framework governing generic drug approval processes in the United States.
Content and Format of Composition in Labeling : NDA's-ANDA's
Requests for Reconsideration at Division Level under GDUFA
eCTD Submission Services: Expert Solutions for Regulatory Compliance
MAPP: Responsibilities for the Assessment of In-Vitro Testing for Oral Drug Products Administered Via Enteral Feeding Tube
FDA Establishment Identifier Services: Navigating Compliance & Regulations Made Easy
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol
Guiding Innovation: 505(b)(2) Regulatory Consulting
Reformulation Drug Products That Contain Carbomers Manufactured with Benzene
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How to Make an FOIA (Freedom of Information Act) Request to FDA
MAPP - Generic Drug Labeling Revisions Under Section 505(j)(10) of the FFD& C Act
Portable Document Format (PDF) Specifications
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EU Advances AI Integration for Enhanced Medical Product Regulation Through Joint HMA-EMA Big Data Steering Group and Regulatory Initiatives
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The European Medicines Agency (EMA) and its European medicines regulatory network partners are working to enable the use of electronic product information (ePI) for human medicines in the European Union (EU).
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Points of Contact for Questions Related to Generic Drugs
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What is a suitability petition?
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Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program-October 2022
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When is any patent considered to be timely filed? What actions must a pending ANDA or 505(b)(2) applicant take if patent information is untimely filed (i.e., late-listed)?
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Can the generics omit braille when it is part of RLD labeling? Read about the USFDA's stand.
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FDA and ASHP Shortage Parameters