FDA

FDA to Lead 7th Annual UDI Conference in Baltimore

The seventh annual UDI Conference kicks off at the Hilton Baltimore June 24-25, an event that entirely dedicated to guidance and training for those impacted by the unique device identification regulation by the FDA. It will be lead by the FDA UDI team.

New FDU Rothman Institute ED Joseph Gulfo to Speak at MD&M East

An entrepreneur of the biopharmaceutical and medical device industries and author of Innovation Breakdown, Dr. Joseph Gulfo will be speaking at the upcoming MedTechWorld’s Medical Design & Manufacturing East conference June 9-11 at the Javits Convention Center in New York City.

FDA to Co-Sponsor ISPE/FDA/PQRI Quality Manufacturing Conference

The International Society for Pharmaceutical Engineering (ISPE), U.S. Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) will bring together international industry and regulatory leaders for three days of open dialogue across the spectrum of modernization in manufacturing, regulatory insights and quality systems at the ISPE/FDA/PQRI Quality Manufacturing Conference June 1 through June 3 in Washington, D.C.

FDA and European Medicines Agency launch generic drug application inspections initiative

The U.S. Food and Drug Administration has released the following news item:

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) have announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.

Abrams Royal Pharmacy Issues Voluntary Recall

Sterility concerns have prompted Abrams Royal Pharmacy to voluntarily recall all unexpired lots of sterile products dispensed nationwide, including injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments, FDA reported on its Web site

FDA Issues Strategic Plan to Address Drug Shortages

In an effort to lessen the impact drug shortages have on public health, FDA has published a strategic plan to improve the agency’s response to imminent or existing shortages and to develop longer-term approaches for addressing the underlying causes of such shortages, the agency reported on its Web site

FDA Releases Final Unique Device Identification Rule

FDA has finalized its Unique Device Identification (UDI) regulation intended to drive consistency in medical device identification. The final rule requires that most medical devices distributed in the United States bear a unique device identifier, the agency posted on its UDI page today.

FDA Releases Draft Guidance on Good Lab Practices

[Targeted News Service] ARLINGTON, Va., Aug. 28 -- The Association for the Advancement of Medical Instrumentation issued the following news release:

Ceptaris Receives FDA Approval for Valchlor

[Global Data Point]--Ceptaris Therapeutics, Inc., a privately held, specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for the orphan drug VALCHLOR™ (mechlorethamine) gel for the topical treatment of stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients who have received prior skin-directed therapy.
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