Last month, FDA announced a plan for revamping the 510(k) Third Party Review Program (the “Program”), which was outlined in a publication, Eliminating Routine FDA Re-Review of Third Party 510(k) Reviews (the “Plan”). One element of the Plan includes the issuance of a draft guidance, …
Late last month, FDA published revised draft guidance, titled “Insanitary Conditions at Compounding Facilities: Guidance for Industry.” The revised guidance comes two years after FDA released its August 2016 draft guidance addressing what it considers “insanitary conditions” during inspections of both Section 503A pharmacies and Section …
In determining whether to submit a Formal Dispute Resolution Request (FDRR) appealing a Complete Response Letter (CRL) or other adverse action from FDA’s Office of New Drugs (OND), applicants necessarily consider how often such appeals are successful. The most cited relevant statistics were published by …
Last Wednesday, October 3, a wide-ranging opioid bill cleared its last legislative hurdle by passing the Senate, and is expected to be signed by the President in the near future. H.R. 6, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (“SUPPORT”) for Patients …
For years, FDA has been looking to reform the Citizen Petition process to address allegations of “gaming” the system to delay competitor approval. This led to the creation of the “505(q)” petition by Congress in 2007 as part of FDAAA, the subsequent revision of the …
On September 25, 2018, FDA issued a final guidance document: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics (“guidance”). A draft of the guidance was issued on July 25, 2014. When reviewing device 510(k)s, FDA’s review of …
On September 28, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed an Amended Complaint seeking declaratory and injunctive relief against implementation and enforcement of California Senate Bill 17 (SB 17). On August 30, 2018, the United States District Court for the Eastern District …
On September 24, the Information Technology and Innovation Foundation (ITIF) petitioned FDA to prohibit the use of the term “Non-GMO” on consumer foods and goods because according to ITIF the claim is misleading. Although the Petition focuses on the Non-GMO Project Verified “butterfly” logo, it asks …
Do you want to understand the latest in FDA’s fast and furious rollout of guidance documents addressing FDA’s regulation of compounding pharmacies and outsourcing facilities? Don’t miss FDANews’ Webinar featuring Hyman, Phelps & McNamara, P.C.’s compounding expert and blogger Karla Palmer, presenting on “Pharmacy Compounding …
On September 28, 2018 FDA issued a new draft guidance document: The Special 510(k) Program (“draft guidance”). The draft guidance was followed by the announcement on October 1, 2018 of a Special 510(k) Pilot Program. The Special 510(k) program was established in 1998 to create a …
It is common for uncertainty to arise during the premarket review of novel medical devices. How CDRH has handled that uncertainty in the context of its benefit-risk assessment has generally been somewhat of a black box. While FDA has issued numerous benefit-risk guidances, the Agency …
In a much-anticipated action since the Food and Drug Administration (“FDA”) approved Epidiolex, G.W. Pharma’s oral cannabidiol (“CBD”) solution for the treatment of seizures associated with Lennox-Gastaut and Dravet syndrome, today the Drug Enforcement Administration (“DEA”) issued a Final Order placing “FDA-approved drugs that contain …
