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…after FDA published a proposed rule and companion direct final rule on April 1, 2010. Due to receipt of significant adverse comments, FDA withdrew the direct final rule. After withdrawal…
…lot of resources to its compliance efforts directed at human drug compounding. OC and CDER continue to use a carrot-and-stick approach with compounders, noting both the creation of the Compounding…
…801.421; id., § 809.30.) The other way for FDA to create restricted devices is by embedding such designations in orders granting premarket application (PMA) approval to Class III devices. (21…
By Ricardo Carvajal – FDA released an online learning module intended “to help the seafood industry, retailers, and state regulators ensure the proper labeling of seafood products offered for sale in…
The Expert Institute recently informed us that the organization is holding a “Best Legal Blog Competition” and that the FDA Law Blog has been selected to participate in the competition. …
…strengthen existing federal law (specifically, the Controlled Substances Analogue Enforcement Act) (“Analogue Act”), which provides that any compound that is chemically or pharmacologically similar to a controlled substance in Schedule…
…component within the U.S. Department of Health and Human Services, is developing guidelines “to provide recommendations for the prescribing of opioid pain medication for patients 18 and older in primary…
…in Subpart M. Q: What are the differences between CMS/CLIA and FD&C Act requirements for complaint records? A: FDA asserted that CLIA’s complaint requirements relate to lab operations/processes (e.g., specimen…
…it received over 38,000 (yes, 38,000!) comments on the proposed rules. DEA is taking these comments “seriously” and is considering them “carefully,” which, by the way, it is generally required…
…complaints, including minor to major medical events, but also complaints about non-medical issues such as off-taste or color of a product. Information in the database includes demographic (e.g., age, gender)…
…asks that comments be submitted to the agency via email, it’s not clear how or when those comments will be made accessible to the public. In any case, an email…
…claims about boosting children’s immunity and cognitive function. Privacy and data security cases were not uncommon during Mr. Vladeck’s tenure; several settlements were announced with companies, such as Google and…
…which have until April 6, 2018 to comply. FDA asserts that “[s]ince the rule has its basis in industry practices, many persons should [already] be in substantial compliance with its…
…with a direct final rule. FDA ultimately withdrew the direct final rule because it received “significant adverse comment[s].” After considering the comments, on February 19, 2013, FDA issued a supplemental…
By Jessica A. Ritsick – This week, the Institute of Medicine (“IOM”) released its report, commissioned by the FDA, “Countering the Problem of Falsified and Substandard Drugs.” The objective was…