The 13th annual WRIB (Workshop on Recent Issues of Bioanalysis) was held in New Orleans, LA this week and is wrapping up today. The workshop was well represented by regulators and industry (both from Pharma and CROs), with numerous discussions and topics for the bioanalysis of small and large molecules. Presentations covered the full spectrum […]
As the FDA and industry prepare for Dr. Gottlieb’s departure from the FDA tomorrow, he and Deputy Commissioner Anna Abram issued a statement (here) on the FDA’s 2019 priorities to improve the quality of compounded drugs. As the statement notes, compounded drug products are not FDA-approved and, thus, can pose a serious threat to the […]
The OGD had what appears to be another good month, fully approving eighty-eight ANDAs and tentatively approving seventeen ANDAs for a total of 105 approval actions. While a few stragglers may still be lurking and not yet listed on the FDA All Approvals page (here), it looks like a good and productive month for the […]
(Westbury, NY – April 2, 2019) Fran Zipp, President and CEO of Lachman Consultants, Inc. a leading provider of compliance, regulatory affairs, and technical services to global life sciences organizations, today announced that Mary Oates has joined the firm as Vice President of Compliance Services. In her role, Oates will lead the expert team that […]
In the not-too-distant past (April 2015), the FDA held a public hearing on potential changes to the enforcement policies and the regulatory approach associated with the marketing of homeopathic drug products. The FDA indicated that it has not had a comprehensive review of the enforcement policies related to these products to reflect changes in […]
