Guidance

01
Jul

FDA Issues Two New Labeling Guidances to Aid Sponsors

The FDA announced the availability of two draft labeling guidance documents today.  One, titled Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products and Drug-Device and Biologic-Device Combination Products—Content and Format (for standardizing the instructions for use section of labeling), and the other, titled Drug Abuse and Dependence Section of Labeling for Human […]

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02
Jan

Linaclotide Guidance Leaves BE Study with Clinical Endpoints as One Option but Also Provides for In Vitro Option as Well

Linaclotide capsules are “minimally absorbed with negligible systemic availability following oral administration.  Concentrations of linaclotide and its active metabolite in plasma are below the limit of quantitation after oral doses of 145 mcg or 290 mcg were administered.  Therefore, standard pharmacokinetic parameters such as area under the curve (AUC), maximum concentration (Cmax), and half-life (t½) […]

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20
Dec

Happy Holidays from Us to You!

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year.  The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]

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03
Dec

OGD Issues Guidance on Post-Complete Response Letter Meetings

The Office of Generic Drugs has issued a guidance titled “Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA” (here) that addresses OGD expectations, procedures for obtaining such meetings, and timeline for scheduling and having the meetings.  As the FDA notes in the guidance: “FDA will only grant post-CRL meeting requests that pose […]

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24
Sep
A 3D representation of the word final hanging on a plain white background. The word is hanging from binder paper…

Final ANDA Submission Guidance Published Today

The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format”   (here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents. There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix […]

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