FDA has issued a list of planned draft and final guidance documents for  release throughout 2012. There are about 50 such 

 planned. Below are a few highlights for the drug-manufacturing space.

Food-Effect Bioavailability and Fed Bioequivalence  Studies—Bioavailability and Bioequivalence Studies for Orally Administered Drug  Products Submitted in New Drug Applications General Consideration

Scientific Considerations in Demonstrating  Biosimilarity To a Reference Product (draft already issued)

Quality Considerations in Demonstrating Biosimilarity  To a Reference Protein Product (draft already issued)

Biosimilars: Questions and Answers Regarding  Implementation of the Biologics Price Competition and Innovation Act of 2009  (draft already issued)

Expiration Dating of Unit-Dose Repackaged Drugs:  Compliance Policy Guide

Importation of Active Pharmaceutical Ingredients (API)  for Use in Human Drugs

In labeling, packaging, and supply chain:

Naming, Labeling, and Packaging Practices to Reduce  Medication Errors

Securing the Drug Supply Chain—Standards for Tracking  and Tracing Prescription Drug Packages

Organ-Specific Warnings: Internal Analgesic,  Antipyretic and Antirheumatic Drug Products for Over-the-Counter Human  Use-Labeling of Products That Contain Acetaminophen

Pediatric Information: Incorporating into Human  Prescription Drug and Biological Products Labeling

Providing Regulatory Submissions in Electronic Format –  General Considerations

Providing Regulatory Submissions in Electronic Format –  Human Pharmaceutical Product Applications and Related Submissions Using the  eCTD Specifications

Providing Regulatory Submissions in Electronic Format –  Study Data

Providing Regulatory Submissions in Electronic Format –  Standardized Study Data

News

FDA has issued a list of planned draft and final guidance documents for release throughout 2012.