www.fda.gov

FDA PRODUCT-SPECIFIC

GUIDANCE SNAPSHOT

What is a Product-Specific 

Guidance?

Since 2007, Product-Specific Guidances 

(PSGs) provide recommendations 

on individual drug products to the 

pharmaceutical industry for developing 

generic drug products.

PSGs describe FDA’s current thinking on 

the evidence needed to demonstrate that a 

generic drug is therapeutically equivalent 

to the reference listed drug (RLD) product. 

As of November 2022, nearly 2,070 PSGs 

have been published. FDA provides 

information on the PSG program to the 

general public here.

Why are PSGs Important?

PSGs assist the generic pharmaceutical 

industry with identifying the most 

appropriate methodology and approaches 

for their generic drug development 

programs, including in vivo and/or in 

vitro bioequivalence (BE) studies, various 

waiver options (such as Biopharmaceutics 

Classification System (BCS)-based 

waiver), and dissolution testing methods.

The clarity and transparency provided 

by PSGs help streamline generic drug 

product development, promote timely 

approval of Abbreviated New Drug 

Application (ANDA) submissions and 

increased drug competition, improving 

patient access to high quality and 

affordable medicines.

What is the Timeline on PSG 

Development for Newly Approved Drugs?

As a commitment under the Generic Drug User Fee 

Amendments (GDUFA) of 2022, FDA issues PSGs for 90% 

of non-complex New Chemical Entities (NCEs) that are 

approved on/after October 1, 2022 within 2 years after the 

date of approval.

For complex products approved in new drug applications 

(NDAs) on/after October 1, 2022, FDA issues PSGs for 

50% of such NDA products within 2 years after the date of 

approval, and for 75% of such NDA products within 3 years 

after the date of approval.

Further information on the GDUFA commitment can be 

found here.
Current and prospective ANDA applicants should contact genericdrugs@fda.hhs.gov. 

All others with inquiries should contact druginfo@fda.hhs.gov. www.fda.gov

When and Where are PSGs Published?

FDA issues new and revised PSGs in batches on a quarterly basis 

and as needed as stand-alone postings.

Published PSGs are announced in the Federal Register and made 

available to the public via FDA’s website found here.

FDA also provides information on upcoming new and revised PSGs 

for generic drug products on a quarterly basis at the website.

Who Collaborates on PSG 

Development?

PSG development is a collaborative 

effort from multiple disciplines and 

offices within the FDA. The FDA aims 

to ensure that policies and regulations 

– and scientific standards – keep pace 

with the science. 

While the Office of Generic Drugs 

takes a leading role in PSG 

development, additional offices 

support the development and 

publication processes.

Initiating Events

• Recently approved NDAs 

and supplemental NDAs

• FDA analysis of products 

without PSGs

• Pre-ANDA meetings

• Public requests

• Comments submitted to PSG 

docket

• Controlled correspondences

• Citizen petitions

Data to Support PSG 

Development

• Pharmacokinetic (PK) and 

pharmacodynamic (PD) 

modeling 

• Previous BE studies

• NDA review and labeling

• Pharmacovigilance

• GDUFA-funded research 

outcomes 

Prioritization

• GDUFA commitments 

• Stakeholder interest 

in ANDA submission

• Drug availability and 

accessibility

• Public requests from generic 

drug industry and other 

stakeholders

• Public health priorities

Total PSGs Published by Fiscal Year 

(2013 - 2022)

0

50

100

150

200

250

300

FY 13 FY 14 FY 15 FY 16 FY 17 FY 18 FY 19 FY 20 FY 21 FY 22

44

57 70

42

86 72

74

145 149 60

61 67

77

153

94

108

110

136

107

107

New Revised

Office of

Generic

Drugs

Office of

Regulatory

Policy

Office of

New Drugs

Office of

Translational

Sciences

Office of

Pharmaceutical

Quality