User fee legislation says facility information to qualify for priority review must arrive two months in advance of ANDA, conflicting with narrow 'window' in FDA's draft guidance.

Key FDA legislation moves to implementation phase with presidential signature but little fanfare.

The pressure is on for API makers to submit higher quality Type II drug master files, or DMFs. FDA official says many US ANDA approvals are delayed by poor quality DMFs. A representative of the generic drug industry, however, contends that FDA is partially to blame for this problem by setting impractical expectations and an unrealistically high bar for DMFs.