Drugs
FDA has accepted for priority review a Genentech supplemental NDA for Zelboraf (vemurafenib) for Erdheim-Chester disease (ECD) with BRAF V600 mutation. ECD is a rare, serious blood disease characterized by the abnormal multiplication of certain white blood cells called histiocytes. The therapy was also granted breakthrough therapy designation for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” The document provides recommendations to BLA holders, describing chemistry, manufacturing, and controls postapproval manufacturing changes that the agency generally considers to have a minimal potential
Drugs
FDA has released for comment a draft guidance on “CMC Post-approval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports.” The document provides recommendations on the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12. Specifically,
Drugs
Federal Register notice: FDA is seeking comments on an information collection for “Providing Waiver-Related Materials in Accordance With the Guidance for Industry on Providing Post-Market Periodic Safety Reports in the International Conference on Harmonization E2C (R2) Format (Periodic Benefit-Risk Evaluation Report).” The guidance is intended to promote
Drugs
A National Cancer Institute study has identified more than 100 genes that may play a role in facilitating tumor destruction by T cells. The researchers published their findings online 8/7 in Nature. A news release says since some tumor cells are resistant to T cell attack, the researchers wanted
Drugs
The Pew Charitable Trusts says it will launch within a year its Shared Platform for Antibiotic Research and Knowledge (SPARK), where researchers can share data, ideas, and insights to spur discovery of innovative new antibiotics. An announcement says the cloud-based resource will “integrate research data with analysis by leading
Devices
Siemens says it is preparing updates for four medical molecular imaging products that run on Windows 7 as a result of identifying vulnerabilities in the products. A TechXplore online post says the Department of Homeland Security reported that the company had identified the vulnerabilities. The department said the vulnerabilities could
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Cellex-C International Toronto, Canada (8/2): FDA inspected the firm in January and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to have, for
Drugs
FDA is recommending that Cellex-C, a Toronto, Canada, drug manufacturer, retain a consultant to help it meet current good manufacturing practice (CGMP) regulations following a 1/16-1/19 agency inspection that found significant violations of the regulations. Specific violations listed in an agency 8/2 Warning Letter were:
Drugs
A 1/30-2/1 FDA inspection at Skin Sciences Laboratory, Pasig City, Philippines, found significant violations of CGMP regulations for finished pharmaceuticals along with misbranding and unapproved new drug violations. A 7/28 Warning Letter lists the violations as: * failing to have, for each batch of drug product, appropriate
Drugs
FDA has released the FDA-483 issued following a 5/25-6/1 inspection at Biocon, a Bangalore, Karnataka, India, sterile drug manufacturer. The 10 inspection observations on the form were: * investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug
Drugs
FDA has announced a 9/18 public meeting to discuss topics related to the structured assessment of benefits and risks in drug regulatory decision-making. The meeting will focus on “regulatory and industry experiences with approaches to structured benefit-risk assessments, approaches to incorporating patient perspectives into structured benefit-risk
Biologics
FDA has cautioned a New York doctor that he must stop marketing in the U.S. a technique called spindle nuclear transfer in which the nucleus of a donor egg is removed and the DNA of another woman’s egg is injected. The doctor, John Zhang, founder of New Hope
Drugs
FDA has published a draft guidance, Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products, describing the conditions under which the agency does not intend to take action regarding required stability studies and expiration dates for repackaged unit-dose solid oral dosage form drug products. The document
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for its “Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics.” The document provides information concerning cooperative manufacturing arrangements applicable to biological products subject to licensure under section 351 of the Public Health Service Act. It addresses several
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Prescription Drug Advertisements.”The agency’s drug advertising regulations describe requirements and standards for print and broadcast advertisements. Advertisements that are broadcast through media such as television, radio, or telephone communications systems must disclose the major risks from
Drugs
As advancing science is fueling new discoveries, FDA needs help from academic scientists to review and approve new drug therapies because in-house talent is weak, according to a Nature editorial. To illustrate the challenges, the editorial points to a 7/12 FDA advisory committee panel that reviewed a Novartis
Devices
FDA has cleared a Mauna Kea Technologies 510(k) for its CelioFlex UHD Confocal Miniprobes for use with the company’s Cellvizio laser endomicroscopy platform in robotic-assisted surgery procedures. The Miniprobes are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures. The
Drugs
FDA has issued Valeant Pharmaceuticals a complete response letter on its NDA for latanoprostene bunod ophthalmic solution, 0.024%, an investigative intraocular pressure-lowering single-agent eye drop for patients with open angle glaucoma or ocular hypertension. The letter cites a GMP inspection at subsidiary Bausch + Lomb’s manufacturing facility
Devices
FDA has cleared a GE Healthcare 510(k) for the Signa Premier, a new wide bore 3.0T magnetic resonance imaging system. The device is the result of a four-year collaboration with the National Football League and research institutions around the world working to design new imaging tools, particularly
Drugs
New research by FDA and RTI International’s Center for Communication Science shows promising data on a new model for presenting risk information in broadcast direct-to-consumer (DTC) prescription drug ads. Designed to address how much information should be included in DTC major risk statements, the research found that
FDA Policy/General
Federal Register notice: FDA has announced the the availability of 48 final product-specific guidances that recommend the design of bioequivalence studies to support ANDAs. To view the guidances, visit here. To view the notice, click here.