General Information

New online platform for PRIME eligibility requests

PRIME is a European Medicines Agency (EMA) initiative to increase assistance for the development of medicines that address an unmet medical need. Through PRIME, the Agency provides early and proactive support to drug developers to maximise the production of reliable data on a medicine’s benefits and risks and to allow accelerated assessment of drug applications. […]


Non-prescription Drug Product with an Additional Condition for Non-prescription Use

The FDA is proposing to establish norms for a non-prescription medication with an additional condition for non-prescription use (ACNU). If implemented, the proposed rule would establish requirements for a non-prescription drug product with an ACNU that an applicant must implement to ensure appropriate self-selection or appropriate actual use, or both, by consumers who are not […]


Cover Letter Attachments for Controlled Correspondence and ANDA Submissions Guidance for Industry

“The format of the cover letter attachment can be customized by the applicant according to their convenience. The primary purpose of the cover letter attachment is to assist applicants in ensuring that they address relevant information in any cover letter they submit to the FDA for the submissions mentioned in this guidance. The cover letter […]



INDUSTRY CONSULTATION ON ELECTRONIC COMMON TECHNICAL DOCUMENT (eCTD) IMPLEMENTATION IN SINGAPORE Overview HSA is planning to introduce eCTD to enable full e-submissions thereby minimising the need for submitting documents using storage media such as CD/DVD ROMs. HSA is working with our appointed vendor to develop the eCTD system (ICH eCTD version 3.2.2) in Singapore. The […]


Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023

Holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before April 1 in order to continue doing business. Those with a suspended MDEL are exempt from applying. An annual licence review (ALR) ensures that MDEL holders are: Adhering to regulatory requirements Maintaining their licence information up […]


Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

According to FDA regulations, if an applicant wishes to pursue approval of its Abbreviated New Drug Application (ANDA), applicant must submit all materials required to fully address all shortcomings in the Complete Response Letter (CRL) within one year of the CRL’s issuance. The applicant must submit a request for an extension on or before the […]

Regulatory Uncategorized

Revising ANDA Labeling Following Revision of the RLD Labeling

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Revising abbreviated new drug applications (ANDAs) Labeling Following Revision of the reference listed drugs (RLDs).” In this guidance, FDA is providing information on How ANDA applicants and holders should monitor for changes to RLD labeling: The sponsor […]

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