Controlled Correspondence Assistance

Masuu US Agent helps pharmaceutical companies in drafting, reviewing, authorizing, submitting, and securing approval from the FDA for FDA Controlled Correspondence (CC) submissions, which allow generic drug manufacturers to request information related to generic drug development prior to submitting an ANDA.

Generic drug manufacturers and industry stakeholders can submit written inquiries to the FDA’s Office of Generic Drugs (OGD) through a process known as FDA Controlled Correspondence. This allows companies to request clarification or guidance on specific aspects of generic drug development or post approval submission requirements.

The GDUFA III commitment letter defines level 2 controlled correspondence as correspondence that meets the definition of level 1 controlled correspondence. The FDA strives to review and respond to 90% of Level 1 Controlled Correspondence within 60 calendar days of submission, and 90% of Level 2 Controlled Correspondence within 120 calendar days.

Level 1 Controlled Correspondence, which includes inquiries submitted to the FDA by or on behalf of generic drug manufacturers or related industry stakeholders and the inquiries can be categorized as follows:
  1. Requests for information on specific elements of generic drug development, including:
    • Before submitting an ANDA (Abbreviated New Drug Application);
    • Following a Product-Specific Guidance (PSG) Teleconference, if further feedback is needed from the FDA;
    • After receiving a Complete Response Letter (CRL) or Tentative Approval;
    • After ANDA approval.
  2. Requests concerning post approval submission requirements that are not addressed by the CDER (Center for Drug Evaluation and Research) post approval changes guidance and are not specific to an ANDA.
Level 2 Controlled Correspondence, as defined by the GDUFA III Commitment Letter, includes all of the above, with additional criteria:
  1. Evaluation of clinical content;
  2. Requests for Covered Product Authorization and review of bioequivalence (BE) protocols involving clinical trials for an ANDA where the reference listed drug (RLD) is subject to a Risk Evaluation and Mitigation Strategy (REMS) with Elements to Assure Safe Use (ETASU);
  3. Requests for Covered Product Authorization to obtain sufficient quantities of an individual covered product subject to REMS with ETASU, without involving clinical trials;
  4. Requests for evaluations of alternative BE approaches (e.g., pharmacokinetic, in vitro, or clinical studies);
  5. Submissions requiring input from another office or center within the FDA.
Masuu has filed a wide array of FDA Controlled Correspondence including.
  • Q1/Q2 sameness with Reference Listed Drug (RLD)
  • Chemistry Questions, RS Designation
  • MDD of Drug Product
  • Alternative BE Approach
  • Bioequivalence Questions
  • Inactive Ingredients, Formulation/Overage
  • Device Evaluation, Guidance Clarification
  • Drug Shortage
  • RLD Assignment/Availability/Status
  • Retention Samples, Labeling Questions
  • Combination Products
  • Dissolution Specification
  • Filing, and more.
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