Regulatory Roundup for Week of January 7, 2013
FDA celebrates 30 years of the Orphan Drug Act.
FDA’s Orphan Drug Act celebrates its 30th year in 2013. Gayatri R. Rao, MD, JD, director for The Office of Orphan Products Development, provides highlights of the past 30 years of the Act.
A list of FDA’s 2012 new, revised, and withdrawn guidance documents can be found at fda.gov.
FDA released the following guidance documents in late December 2012 and early January 2013:
• Guidance for Industry, Providing Regulatory Submissions in Electronic Format—Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, draft guidance, FDA, CDER, CBER, January 2013. This guidance provides the requirements for a valid electronic submission under section 745A(a) of the FD&C Act.
• Guidance for Industry and Investigators, Safety Reporting Requirements for INDs and BA/BE Studies, FDA, CDER, CBER, December 2012. This guidance is intended to help sponsors and investigators comply with the requirements for investigational new drug (IND) safety reporting and safety reporting for bioavailability (BA) and bioequivalence (BE) studies under 21 CFR 312.32, 312.64(b), and 320.31(d)(3).
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
Intertek to Expand UK GMP Facility with 6000 Square Feet of Lab and Office Space
May 7th 2025The company said the expansion is in response to globally rising demand for inhaled biologics, which offer distinct advantages in route of administration, but can be challenging products for developers.
