Hyman, Phelps & McNamara, P.C. ("HP&M") has once again been ranked as a “Tier 1” law firm in the area of “FDA Law” (both nationally and in Washington, D.C.) by the folks over at U.S. News & World Report, who teamed up with Best Lawyers …
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Hyman Phelps McNamara
- U.S. News & World Report Ranks HP&M as Top Tier FDA Law Firm (Again!)November 8th, 2016
- There’s a New Reporting Tool in TownNovember 3rd, 2016
By Jennifer M. Thomas – Last week, FDA rolled out a new online reporting program, titled “Reporting Allegations of Regulatory Misconduct,” with little fanfare. No blog post in FDA Voice, no press conference, and even the (longwinded) name of the program seems calculated to send the …
- Keeping Up with ….. FDA’s Drug Compounding Lists: Todays PCAC MeetingNovember 2nd, 2016
By James E. Valentine & Karla L. Palmer – There are a number of lists that are central to FDA’s regulatory framework for the regulation of pharmacy compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetics Act (FD&C Act). In recent posts, …
- Is it Time for a Single Food Agency?November 2nd, 2016
That will be among several food policy topics discussed this Friday at a Food and Drug Law Journal Symposium titled Law and Food Systems: Institutional Pathways Toward a New Paradigm? Proposals for a single food agency have bubbled up over the years, and the impending election …
- Webinar: From Wearables to Big Data – A Cross-Disciplinary Discussion of Digital Health Legal IssuesNovember 1st, 2016
Technology continues to change the landscape of healthcare and companies are seeking new and innovative ways to leverage advances in other fields to improve quality of care and the diagnosis and treatment of disease. In doing so, they are required to navigate an increasingly complex …
- Draft Guidance Addresses Suppliers’ Disclosure of Uncontrolled Hazards in Foods October 30th, 2016
By Ricardo Carvajal – FDA issued a draft guidance document that addresses disclosures required to be provided by a supplier when certain hazards in food have not been controlled. A disclosure requirement is included in four of the FSMA rules, namely the preventive controls rule for …
- The Update Continues: FDA’s List of Drugs that May Not Be Compounded Under 503A and 503BOctober 27th, 2016
By James E. Valentine & Karla L. Palmer – We reported earlier this month that the Food and Drug Administration (FDA) amended its regulations to update the list of drugs that may not used in compounding under the exceptions set forth in sections 503A and 503B …
- DEA Administrative Hearings: “Open to the Public” Requires Notice to the PublicOctober 26th, 2016
By John A. Gilbert, Jr. & Andrew J. Hull – The Controlled Substances Act (“CSA”) and regulations promulgated by the Drug Enforcement Administration (“DEA”) provide for a right to an administrative hearing in matters where DEA seeks denial or revocation of a DEA registration to handle …
- DEA Administrative Decisions Update: DEA’s Questionable Practice of (Un)official NoticeOctober 25th, 2016
By Karla L. Palmer & Andrew J. Hull – From time to time, we have posted on significant final orders in DEA administrative cases. We now plan to blog on these cases in a more regular fashion, partly because we have noted that a number of these …
- In a Veloxis-Like Analysis, FDA Rules That EMBEDA 3-Year Exclusivity Does Not Block MORPHABOND 505(b)(2) ApprovalOctober 24th, 2016
By Kurt R. Karst – There are few things this blogger likes more (workwise at least) than having a hot cup of joe in the morning while reading through an FDA exclusivity decision. (Reading through the latest edition or supplement to the Orange Book while enjoying …
- Who you Gonna Call . . . . to Resolve a Compliance Status Block on Approval?October 24th, 2016
By Robert W. Pollock* & Kurt R. Karst – If there’s something strange in your neighborhood; Who you gonna call? If there’s something weird, and it don't look good; Who you gonna call? Unfortunately, FDA doesn’t have a Ghostbusters-type unit to call when there’s something strange …
- Promoting Your 510(k)-Pending Device: 5 Questions About FDA’s PolicyOctober 20th, 2016
For almost 40 years FDA has allowed device firms to promote their device while a 510(k) submission is still pending. Yet, questions about how to apply this policy still remain. In an article newly published in MedTech Insight, titled "Promoting Your 510(k)-Pending Device: 5 Questions …
- FSIS Issues Update to Guideline Regarding Animal-Raising ClaimsOctober 19th, 2016
By Riëtte van Laack – A couple of weeks ago, the Food Safety Inspection Service of the USDA (FSIS) announced the availability of an updated compliance guideline regarding animal-raising claims. The previous guideline dated from 2002. Traditionally, the FSIS has interpreted the Federal Meat Inspection Act (“FMIA”) …
- As the Patient-Focused Drug Development “Pilot” under PDUFA V Concludes, Is FDA Passing the Baton to Patient Organizations?October 18th, 2016
By James E. Valentine – In what can only be described as a success story, FDA’s Patient-Focused Drug Development (“PFDD”) initiative has opened the doors to hundreds of patients, caregivers, and other patient representatives to share their experiences with their diseases and conditions with FDA. This …
- A Phoenix Rising from The Ashes: FDA Proposes a Rule Requiring Submission of Device Labels and Package InsertsOctober 17th, 2016
By Jeffrey K. Shapiro – In 1976, FDA first began comprehensive regulation of medical devices. Among the new statutory provisions, there was one requiring persons registering with FDA to list all marketed devices. Each device on the list was to be accompanied by a copy of …