FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says an Eli Lilly social media post for Trulicity (dulaglutide) injection, for subcutaneous use, “makes false or misleading claims and representations about the benefits and risks of Trulicity.” A 1/19 Notice of Violation says the FDA Bad Ad program received a
FDA Policy/General
Hanzo compliance product manager Will Walker says FDA-regulated companies need to have fully functional, interactive Web site archives that they can use to prove to FDA that their advertising and promotional content was and is in compliance with regulations. Writing in an online post, Walker says that without an
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Principles for Selecting, Developing, Modifying, and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Evaluation.” The document describes principles that should be considered when using such instruments in evaluating medical devices and provides recommendations about the importance
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Studies.” The document was developed based on a recommendation by the agency’s Patient Engagement Advisory Committee for a framework to clarify how patient advisors can engage in
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says its concerns about a series of Lilly ads for Emgality (galcanezumab-gnim) injection for subcutaneous use have been satisfactorily answered by the company. OPDP expressed its concerns in a 12/13/21 Notice of Violation that said the TV spots featuring
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR part 866” (OMB Control Number 0910-0584). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Exports Notification and Recordkeeping Requirements — 21 CFR 1.101” (OMB Control Number 0910-0482). The collection applies to exporters who have notified FDA of their intent to export unapproved products that may not be sold or offered
FDA Policy/General
FDA Seeks Comments on Covid Guidances 1/21/2022 Federal Register notice: FDA is announcing recent guidance documents related to the Covid-19 public health emergency. Under emergency procedures, the documents have been implemented without prior comment, but they remain subject to comment in accordance with the agency’s good
FDA Policy/General
Eagle Pharmaceuticals has entered into an agreement to acquire drug formulation and delivery company Arsia Therapeutics for $30 million. Arsia’s technology is designed to allow subcutaneous administration of high-dose biologics. The technology comprises a library of excipients that disrupt interactions between protein molecules without interfering with the proteins
FDA Policy/General
BIOLOGICS FDA has approved an Amgen supplemental BLA for Blincyto (blinatumomab) to include new data supporting the treatment of pediatric patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The company says this indication is approved under accelerated approval, and continued approval may be
FDA Policy/General
Federal Register notice: FDA is announcing recent guidance documents related to the Covid-19 public health emergency. Under emergency procedures, the documents have been implemented without prior comment, but they remain subject to comment in accordance with the agency’s good guidance practices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled Collecting and Providing 702(b) Portions of FDA Official Samples — Questions and Answers. Under Section 702(b) of the FD&C Act, when FDA collects a sample of a food, drug, or cosmetic for analysis, FDA must, upon
FDA Policy/General
Federal Register notice: FDA is announcing the revocation of the Emergency Use Authorizations (EUAs) issued to Cellex Inc. for the Cellex q–SARS–CoV–2 IgG/IgMRapid Test, BioMerieux SA for the SARS–COV–2 R–GENE, Siemens Healthcare Diagnostics Inc. for the Atellica IM SARS–CoV–2 IgG (COV2G)
FDA Policy/General
Federal Register notice: FDA is seeking comments on its proposal to classify human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices into Class 2 (special controls). The agency says it does not intend to exempt these device types from premarket notification requirements. After considering comments, FDA will publish
FDA Policy/General
Federal Register notice: FDA is classifying retinal diagnostic software devices into Class 2 (special controls). The action is in response to an IDx de novo classification request for its IDx-DR device. The agency has identified these as prescription software devices that incorporate an adaptive algorithm to evaluate ophthalmic images
FDA Policy/General
FDA has extended until 2/4 a temporary postponement of certain inspection activities due to the spread of the omicron variant. Late last year, the agency said it had temporarily postponed until 1/19 all face-to-face domestic and foreign inspectional work except for “mission-critical” inspections (see earlier
FDA Policy/General
Three Skadden Arps attorneys say life sciences companies may face policy changes and increased enforcement activity from FDA and the Department of Justice (DoJ) as 2022 plays out. Writing in an online post, the attorneys say that so far the Biden administration’s FDA and DoJ have focused their efforts
FDA Policy/General
Federal Register notice: FDA is correcting a 10/22/2021 notice that announced the withdrawal of 216 ANDAs. The document was published with an incorrect date, and it wrongly indicated that Bio-Nucleonics’ ANDA 075941 for strontium chloride SR–89 injection was being withdrawn. To view the notice, click here.
FDA Policy/General
DEVICES FDA has cleared a Bone Index Ltd. 510(k) for its second generation Bindex point-of-care device model to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a “Density Index,” a parameter which estimates bone mineral density at
FDA Policy/General
HUMAN DRUGS FDA has approved an Allergan NDA for Byvalson (nebivolol and valsartan) 5 mg/80 mg tablets, indicated for treating hypertension to lower blood pressure. The company says the product is the first fixed-dose combination of a beta blocker and angiotensin II receptor blocker available in the U.
FDA Policy/General
Pepcid Not Withdrawn Due to Safety/Efficacy: FDA 1/14/2022 Federal Register notice: FDA has determined that Valeant Pharmaceuticals’ Pepcid (famotidine) tablets, 20 mg and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. Pepcid is indicated in adult and pediatric patients for treating active
FDA Policy/General
Adventrx Pharmaceuticals has provided details on a Phase 3 clinical study it plans to initiate this quarter of ANX-188 (purified poloxamer 188) in sickle cell disease. The study will be conducted at about 40 sites mostly in the U.S. with a primary objective of demonstrating that ANX-188