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June 11, 2009
The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009.
The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.
June 04, 2009
This week the US Food and Drug Administration released the final version of Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing.
June 02, 2009
Short-term problems in software or hardware lead to long-term manufacturing troubles.
May 28, 2009
The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices.
May 07, 2009
The US Food and Drug Administration issued a draft guidance for industry, Label Comprehension Studies for Nonprescription Drug Products, in the May 1 Federal Register.
May 02, 2009
Process steps, GMP documents, a purification vessel, and validation seem to disappear.
May 01, 2009
The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them.
April 23, 2009
The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).
The US Food and Drug Administration issued a draft guidance for industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs).