Drugs
A 1/29-2/26 FDA inspection at Hanlim Pharm Co., Gyeonggi-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/3 Warning Letter says the specific violations were: * failing to follow appropriate written procedures that are designed to prevent microbiological
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a Facebook post and associated comments on MannKind’s Afrezza (insulin human) inhalation powder, for oral inhalation use, make false or misleading claims and/or representations about the risks associated with Afrezza by suggesting that there are no safety concerns associated
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is is intended to assist sponsors planning to use minimal residual disease as a biomarker in clinical trials.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.” The document describes general approaches to evaluating the benefits and risks of targeted therapeutics within a clinically defined disease where some molecular alterations may occur at low frequencies.
Drugs
A 5/29-6/8 FDA Bioresearch Monitoring Program inspection determined that Ignatius Godoy, Paramount, CA, violated regulations governing the proper conduct of clinical studies involving investigational new drugs in his role as clinical investigator in a study of a quadrivalent inactivated influenza virus vaccine in a pediatric population. A
Devices
The Kidney Health Initiative, a public-private partnership between the American Society of Nephrology, FDA’s CDRH, academia, industry, and patient groups, intends to advance scientific understanding of kidney health and foster development of therapies for kidney diseases. The group’s Regulatory Considerations Affecting Device Approval project was designed to:
FDA Policy/General
FDA is soliciting comments on proposed research entitled “Disease Awareness and Prescription Drug Promotion on Television.” A Federal Register notice says that when pharmaceutical companies market a new drug, “they often also release disease awareness communications about the medical condition the drug is intended to treat. FDA is interested in
FDA Policy/General
FDA has issued a draft guidance, Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements, covering human drugs and biological products and prescription animal drugs and in DTC promotional materials for over-the-counter animal drugs. The document says quantitative efficacy and risk information refers
Drugs
FDA has approved Pfizer’s Talzenna (talazoparib), a poly (ADP-ribose) polymerase inhibitor for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on results from companion diagnostic BRACAnalysis CDx test (Myriad Genetic Laboratories), an
Drugs
FDA has outlined a three-factor approach it uses to evaluate whether a drug- or device-related product communication is consistent with the product’s agency-required labeling. The factors come on the heels of a related guidance entitled Medical Product Communications That Are Consistent With the FDA-Required Labeling
Devices
TearLab Corp. says FDA has rejected a 510(k) for its TearLab Discovery MMP-9 test for dry eye disease, and found that the device did not meet the criteria for substantial equivalence based upon data and information submitted by the firm. The agency provided guidance to the company and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hanlim Pharm Co. Seocho-Dong, South Korea (10/3): FDA inspected the firm in February and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to
Drugs
As part of its continuing push to modernize clinical trials, FDA 10/15 released two guidance documents to provide greater clarity and recommendation for drug developers. The first is a draft guidance, Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for
FDA Policy/General
Presumably to avert new FDA regulations or legislation on adding price information in direct-to-consumer (DTC) ads, Pharmaceutical Research and Manufacturers of America (PhRMA) has modified its existing voluntary DTC principles to require member companies to include information in their television ads about how consumers can find pricing details
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Rare Diseases: Early Drug Development and the Role of Pre-Investigational New Drug Application Meetings.” The document offers recommendations on planning and conducting more efficient and productive pre-IND meetings. To view the notice, click here.
Devices
FDA has classified as a Class 1 recall an Endologix safety notice to healthcare professionals about its AFX Endovascular AAA [abdominal aortic aneurysm] System and the risks associated with Type III endoleaks. The device is indicated for treating abdominal aortic aneurysms. When a Type III endoleak occurs, blood continues to
Devices
FDA has cleared a Civco Radiotherapy 510(k) for its Solstice SRS Immobilization System. The device offers “corrective pitch capability and positioning flexibility,” according to the company. It features customizable components to immobilize the patient’s head and neck during radiotherapy. The system comprises a carbon fiber head support, customizable
Biologics
CBER has sent an untitled letter to the operator of two Web sites — http://www.ollereg.com and http://www.innovativeallergy.com — because they were promoting an unapproved product, Ollereg Oral Immunotherapy. Based on statements and claims appearing on the sites, CBER says it “appears that your product is intended
Drugs
FDA has approved EyePoint Pharmaceuticals’ Yutiq (fluocinolone acetonide intravitreal implant) for treating chronic non-infectious uveitis affecting the posterior segment of the eye. The product uses the company’s Durasert drug delivery technology and is a non-bioerodible intravitreal micro-insert in a drug delivery system containing 0.18 mg
FDA Policy/General
Notice on Pathogen Reduction Workshop Corrected Federal Register notice: FDA corrects a 9/17 notice announcing an 11/29 public workshop entitled “Pathogen Reduction Technologies for Blood Safety.” 10/12/2018 FDA Renews Dermatologic/Ophthalmic Drugs Panel Charter Federal Register notice: FDA renews the charter of its Dermatologic and Ophthalmic
Drugs
Novartis has agreed to buy Bannockburn, Illinois-based AveXis for $8.7 billion. As part of the deal, Novartis will gain lead gene therapy candidate AVXS-101 for spinal muscular atrophy. A BLA submission is planned for the second half of this year. Ferring Pharmaceuticals has agreed to acquire Rebiotix,
Drugs
FDA has released a guidance entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” In 2017, revisions were made to HHS’ Federal Policy for Protection of Human Research Subjects (45 CFR 46, Subpart A; “the Common Rule”), which set a 1/21/2019 compliance