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 1. Home
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 3. Drug Safety and Availability
 4. FDA issues series of guidances under Drug Competition Action Plan

 1. Drug Safety and Availability


FDA ISSUES SERIES OF GUIDANCES UNDER DRUG COMPETITION ACTION PLAN

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[January 26, 2022] This week, FDA published a series of guidances focused on
generic drug application submissions, labeling, and review. These guidances are
part of our continued efforts to bring greater efficiency and transparency to
the generic drug review process, which helps spur competition and improves
consumer access to the medicines they need at affordable prices.  Bringing more
competition to the market and addressing the high costs of medicines are top
agency priorities.
 
These guidances support FDA’s Drug Competition Action Plan (DCAP), which
encourages robust and timely market competition for generic drugs. Offering
clarified, up-to-date guidance for industry demonstrates FDA’s commitment to
bringing more high-quality, safe, effective, and affordable generic medicines to
all consumers. 

This week’s published guidances include:

Information Requests and Discipline Review Letters Under GDUFA Final Guidance 

FDA first issued Information Requests and Discipline Review Letters Under GDUFA
as a draft guidance in 2017. The final guidance describes how the agency issues
and uses information requests (IRs) and discipline review letters (DRLs) during
the assessment of an original abbreviated new drug application (ANDA). 

We are committed to providing generic drug applicants with preliminary thoughts
on possible deficiencies through an IR or DRL as each assessment discipline
finishes its initial assessment of its application portion. When applicants
receive our feedback around the mid-point of the review period, they have the
opportunity to resolve issues in that same assessment cycle. IRs and DRLs as
described in this guidance will improve the predictability, transparency, and
efficiency of FDA’s assessment process. By reducing the number of assessment
cycles needed for approval, FDA can approve more applications for safe,
effective, high-quality generic drugs and increase Americans’ access to
affordable medicines.

FDA also revised the accompanying Manual of Policies and Procedures (MAPP
5220.5), Issuance of Information Requests and/or Discipline Review Letters for
ANDAs. The MAPP describes how the generic drug program issues IRs and DRLs for
ANDAs, which will help enhance consistency and predictability in FDA’s
communications with industry.  

Revising ANDA Labeling Following Revision of the RLD Labeling Revised Draft
Guidance

FDA’s draft guidance for industry, Revising ANDA Labeling Following Revision of
the RLD Labeling, provides recommendations for updating labeling for ANDAs
following approved revisions to the labeling of a reference listed drug (RLD),
including how to monitor for RLD labeling updates, how to submit labeling
updates to both unapproved and approved ANDAs to conform to RLD labeling
updates, and other considerations for submitting a labeling update to FDA. The
agency first issued this draft guidance in April 2000 and has updated it with
details on obtaining information on RLD labeling changes and submitting revised
ANDA labeling to FDA, consistent with Generic Drug User Fee Amendments (GDUFA)
procedures.

FDA expects an ANDA holder to update its labeling after the agency has approved
relevant changes to the labeling for the corresponding RLD. By facilitating
prompt submission of labeling changes to unapproved ANDAs to conform to RLD
labeling updates, the agency expects this guidance to help ensure more timely
ANDA approvals and enable patient access to generic drugs sooner.

Good ANDA Submission Practices Final Guidance

The agency first issued the guidance for industry, Good ANDA Submission
Practices, in 2018. It highlights common, recurring deficiencies in ANDAs that
may lead to approval delays. The guidance also provides recommendations on ways
potential and current applicants can avoid these common deficiencies, which may
reduce the number of review cycles necessary to meet ANDA approval requirements.

Multiple review cycles are highly inefficient, require significant resources
from applicants and FDA, and delay patient access to more affordable generic
drugs. By providing recommendations to applicants on how to avoid these common
deficiencies, this guidance will help applicants submit high-quality, complete
applications the agency can approve in the first review cycle. 

Learn more about DCAP and FDA's efforts to enhance generic market competition
and improve consumer drug access.
 


   CONTENT CURRENT AS OF:
   
   01/26/2022


 * REGULATED PRODUCT(S)
   
    * Drugs

 * Drug Safety and Availability
    * Information about Nitrosamine Impurities in Medications
    * Drug Alerts and Statements
    * Medication Guides
    * Drug Safety Communications
   
    * Drug Shortages
    * FDA Drug Safety Podcasts
    * Information by Drug Class
    * Medication Errors Related to CDER-Regulated Drug Products
    * Postmarket Drug Safety Information for Patients and Providers
    * Risk Evaluation and Mitigation Strategies | REMS
    * Safe Use Initiative
    * Drug Recalls
    * Drug Supply Chain Integrity
    * Multistate outbreak of fungal meningitis and other infections




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