Unsecure Email Addresses, Varying Sponsor Names Among Pitfalls in ANDA Submissions, FDA Says

Wrong telephone numbers, unsecure email addresses and inconsistent sponsor names are among the common mistakes the FDA sees in regulatory submissions for generics that can trigger delays in the review process.

The FDA identified issues across generics submissions — including the Form FDA 356h, which is required with an ANDA; transfer of ownership applications; ANDA consolidations; and withdrawals.

Common mistakes in a Form 356h include not providing chemical names, insufficient information on reference drug products and failing to list all facilities associated with the manufacturing, packaging and control sites for both drug substances and drug products.