Sponsors commonly receive a request for additional information (AI) during Food and Drug Administration (FDA) review of a 510(k) submission, de novo classification request, or premarket approval application. In some cases, a sponsor may conclude that one or more AI requests calls for information that …
In early 2016, CMS issued a proposed rule to test new models for the payment of drugs and biologics under Medicare Part B (see our previous post here). The current statutory payment methodology for most drugs under Medicare Part B is the Average Sales Price …
On September 28, 2017, the Department of Health & Human Services’ Office of Inspector General (OIG) released its internal report on FDA’s domestic food facility inspections. The “key takeaway”: “FDA should do more to ensure that the food supply is safe by taking swift and …
In July of last year, FDA released a draft guidance on evaluation and reporting of age-, race-, and ethnicity-specific data in medical device clinical studies (see our post on the draft guidance here). On September 12, 2017, FDA released the final version of this guidance. The …
Pushing forward with his commitment to accessibility, Commissioner Gottlieb recently announced further efforts to encourage generic approval. In another FDA Voice Blog Post, Dr. Gottlieb reiterated the agency’s renewed focus on drug pricing and competition and announced new measures to aid in the development of …
Occasionally we peruse FDA’s inventory of food and color additive petitions under review as a reminder of what might lie on the horizon. The current list includes some that have gotten considerable attention, and others that have largely flown below radar. Among the latter, one stands …
Hyman, Phelps & McNamara, P.C., the nation’s largest boutique food and drug regulatory law firm, seeks an attorney to work with our drug development team. The attorney will assist our clients secure FDA approval for new drugs by leveraging our legal expertise of the approval …
Late last month, Judge Wolf, in the federal district court for the district of Massachusetts, dismissed a putative class action against a number of defendants based on impossibility preemption. The plaintiffs’ basic allegations were that the defendants, all of which manufactured or distributed prescription eye drops, …
Earlier this year, a front page story in the Washington Post spotlighted several cases of fraudulent organic certificates, raising questions about organic certification practices overseas. Now, a new report by USDA’s Inspector General (IG) report confirms those doubts. The IG reviewed the process used by the …
We have witnessed this past week some noteworthy activity in the drug compounding space. Where will this lead traditional compounders and outsourcing facilities? What will it mean for compounders in the months ahead? We will just have to wait until FDA releases anticipated draft guidance …
On September 26, 2017, FDA combined and finalized two Draft Guidance documents first issued in 2011 that set forth the Agency’s approach to classifying products as “drugs” or “devices” under the FDC Act § 201. In doing so, FDA trimmed significant portions of both Draft …
On September 29, 2017, the Health Resources and Services Administration (“HRSA”) published, in the Federal Register, the Final Rule delaying the effective date regarding the methodology for calculating the 340B ceiling price (including the so-called penny pricing policy) and civil monetary penalties (“CMPs”) for knowing …
In what may appear to the uninitiated as a step to cooperate with industry on FDA development of a rational policy for new dietary ingredients (NDIs), FDA is holding a public meeting on October 3 with the goal of developing an authoritative list of old …
As readers of this blog know, in 2016 FDA published a final rule amending the nutrition labeling regulations. Although the industry requested more time to come into compliance with that final rule (which requires revision of virtually every food label), FDA set the compliance date …
The American Conference Institute’s (“ACI’s”) Food Law Regulation Boot Camp is slated to take place at the Wyndham Grand Chicago Riverfront in Chicago, Illinois from November 13-15, 2017. The conference is billed as a way to “[c]onnect the dots of food regulatory law and gain …
