FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices.” The document explains FDA’s compliance policy regarding Global Unique Device Identification Database (GUDID)
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of three NDAs from multiple holders because they repeatedly failed to file required annual reports. They are: * NDA 008284 — Panray Corp’s cortisone acetate tablets (5 mg and 25 mg) * NDA 009659 — Panray Corp’s hydrocortisone tablets (10 mg and 20 mg) * NDA
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Eli Lilly’s Tauvid (flortaucipir F–18), indicated for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles in adult patients with cognitive impairment who are
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Real-Time Oncology Review (RTOR).” The document provides recommendations to applicants on the process for submitting certain NDAs/BLAs with oncology indications for review under the review program. RTOR promotes earlier submission of topline results (i.e., efficacy and
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — Dose Banding.” The document is intended to assist applicants in incorporating dose banding information into the drug labeling
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Evaluation of Therapeutic Equivalence.” The document explains how the agency evaluates generic drug therapeutic equivalence assignments for inclusion in its Orange Book. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 9/22-23 Oncologic Drugs Advisory Committee meeting. On 9/22, panel members will discuss a Spectrum Pharmaceuticals NDA for poziotinib tablets, indicated for treating patients with previously treated, locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion
FDA Policy/General
Federal Register notice: FDA has determined that Fresenius Kabi’s Xylocaine (lidocaine hydrochloride) topical solution 4% was not withdrawn from sale due to safety or effectiveness issues. The determination allows FDA to approve ANDAs that reference the product as long as relevant legal and regulatory requirements are met. The product
FDA Policy/General
The Veeva Field Trends 2022 report says that in-person now accounts for about 70% of interactions between drug company field staff and healthcare providers. “Although in-person is again the predominant channel,” the Veeva report says, “now that 75% of healthcare providers expect a blend of digital engagement, field
Drugs
The Washington Legal Foundation (WLF) says a 7/29 HHS Office of Inspector General (OIG) advisory opinion rejecting a proposal to permit pharmaceutical and medical device industry sponsorship of a continuing education program for healthcare providers “could have significant implications for how life sciences companies contribute towards continuing education programs
FDA Policy/General
Federal Register notice: FDA is making available draft guidance #100 entitled “Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2).” The document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the target animal and for residues in products derived from treated
FDA Policy/General
Federal Register notice: FDA is announcing the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model Implementation Guide (ADaMIG) and the date that this version update is required in certain submissions. Support for versions 1.2 and
FDA Policy/General
Senator Richard Burr (R-NC) has introduced a watered-down FDA user fee reauthorization bill that is intended to address Republican concerns over the current user fee package that the Health, Education, Labor and Pensions (HELP) Committee marked up last month. HELP committee ranking member Burr said the new measure
FDA Policy/General
Federal Register notice: FDA is revoking the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell SARS–CoV–2 Coronavirus Real-time RT–PCR Detection Kit because the company told the agency that the device is no longer being distributed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products — Content and Format.” The document provides recommendations for developing the content and format of an Instructions for Use document for prescription drug and biological products, as well
FDA Policy/General
Federal Register proposed rule: FDA is proposing to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to use certain methods of analysis for FDA enforcement programs when the method is not prescribed in a regulation. The agency believes that the regulation is unnecessary. Absent specifying
FDA Policy/General
The House Energy and Commerce Committee leadership is urging the Senate to “urgently” reauthorize FDA’s user fee programs. “Unless the Senate acts urgently to meet its deadline, FDA will be forced to issue reduction-in-force notices and furlough thousands of workers who ensure the safety and efficacy of
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Genentech’s Enspryng (satralizumab-mwge), indicated for treating neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive. The regulatory review period is 2,495 days, of which 2,128 days
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf), indicated for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Kris A. Hampton-Bey II for a period of five years from importing or offering for import any drug into the U.S. FDA says it based the debarment on a finding that he engaged in a pattern of importing or
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Dr. Reddy’s Xeglyze (abametapir), indicated for the topical treatment of head lice infestation in patients six months of age and older. The regulatory review period is 4,573 days, of which 2,797 days
FDA Policy/General
Federal Register notice: FDA has determined that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to safety or effectiveness issues. The determination allows FDA to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Reglan is indicated for relieving symptoms associated