The FDA will issue a final rule tomorrow making certain data elements required for other FDA-regulated products in 21 CFR § 1.72 also mandatory for the electronic filing of entries containing a veterinary device.
The elements include 1) FDA Country
The FDA will issue a final rule tomorrow making certain data elements required for other FDA-regulated products in 21 CFR § 1.72 also mandatory for the electronic filing of entries containing a veterinary device.
The elements include 1) FDA Country…
FDA is looking for input on distributed manufacturing (DM) and point-of-care (POC) manufacturing of drugs. Typically, pharmaceutical companies produce drugs at larger, rooted facilities, but many are designing technologies and practices to develop their products at smaller, mobile drug manufacturing…
A study commissioned originally by Public Health England and now by the Office for Health Improvement and Disparities showed that vaping poses a fraction of the risks of smoking and is at least 95% less harmful than smoking.
Dr. Brian…
The FDA finalized its guidance document Electronic Submission Template for Medical Device 510(k) Submissions in order to introduce submitters to the current resources made publicly available to support 510(k) submissions. A 510(k) is a premarket submission made to FDA to…
Sponsors of the CBD Product Safety and Standardization Act (H.R. 6134) expressed disappointment with technical assistance the FDA provided in response to their legislation, calling it “a completely insufficient response.” The bill requires FDA to regulate food containing cannabidiol (CBD)…
A federal court ordered Morton Grove Pharmaceuticals on Friday to stop “directly or indirectly manufacturing, processing, packing, labeling, holding, or distributing any drug” product citing GMP regulations. The company is restrained from the aforementioned activity until its GMP operations are…
The FDA on Tuesday issued a rule approving the sale of over-the-counter hearing aids. The move could save consumers thousands of dollars and also opens the door for increased competition. In anticipation of Agency approval, companies such as Bose have…
The Court of Appeals for the Second Circuit ruled Monday that Pfizer’s program to make its drug tafamidis more affordable violated the federal Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a-7(b)(2)(B).
The drug is currently the only drug approved by the…
The FDA will seek external review of its Food Safety and Tobacco offices, Commissioner Robert Califf announced Tuesday. The announcement is most likely a reaction to scrutiny over the handling of certain tobacco and food matters – specifically its regulation…
On July 6, FDA announced the availability of a final guidance for industry entitled “Hazard Analysis and Risk-Based Preventative Controls for Food for Animals.” The guidance is intended to help animal food facilities comply with the hazard analysis and risk-based…