Drugs
Four CDER staffers say that the drug industry, academia, and regulatory agencies need to make a collaborative effort to develop new approaches and technologies for in vivo in vitro correlations (IVIVC) so they can be better used in drug development and post-approval manufacturing changes. Writing in the AAPS Journal,
Drugs
FDA has told Ocular Therapeutix that corrective actions detailed in a response to an inspection Form 483 appear to address the 10 observations that led to a complete response letter for its NDA on Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in treating ocular pain occurring after ophthalmic
FDA Policy/General
U.S. marshals, on behalf of FDA, have seized more than 100 cases of products labeled as containing kratom from Nature Therapeutics LLC, which does business as Kratom Therapy (Grover Beach, CA). The U.S. Department of Justice has filed a complaint in central California federal court, alleging that the
Drugs
Par Sterile Products is asking FDA not to approve any ANDA for an epinephrine injection 1 mg/mL product in a 1 mL vial, ampule, pre-filled syringe or similar parenteral administration modality unless the generic product contains the same inactive composition as would the reformulated Par Adrenalin (epinephrine injection)
FDA Policy/General
Former FDA Webview consulting editor and longtime FDA stalwart John H. Scharmann died in hospice care 8/3 at the age of 84, after a lengthy, valiant battle with kidney disease. He leaves his devoted wife Marlene, daughter Beth and son Phil, three grandchildren and two great-grandchildren. Scharmann joined
Drugs
Citizens Against Government Waste (CAGW) president Tom Schatz says that FDA decisions on biosimilar labeling could “create obstacles in biosimilars by both sending a signal that they are not as safe or effective as their corresponding brand-name biologics, and raising questions about the two types of drugs that are
Devices
FDA has cleared a Luminex 510(k) for the Aries Flu A/B & RSV Assay. The test delivers results in less than two hours for detecting and differentiating three key respiratory pathogens: influenza A virus, influenza B virus, and respiratory syncytial virus. The company says the assay also allows
Drugs
FDA has published a draft guidance, Insanitary Conditions at Compounding Facilities, to assist compounding facilities in identifying insanitary conditions so they can implement appropriate corrective actions. The document says it also is intended to assist state regulators in understanding some examples of what the agency considers to be insanitary conditions
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information, “Agreement for Shipment of Devices for Sterilization — 21 CFR 801.150,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is making available a draft guidance entitled Medical X-Ray Imaging Devices Conformance With IEC Standards. It describes FDA’s policy on regulating medical x-ray imaging equipment that is subject to requirements in the FD&C Act and the agency’s regulations that apply
Drugs
Nine healthcare advocacy organizations representing pharmacists, pharmacies, payers, pharmacy benefit managers, and other stakeholders have written to key members of both the House and Senate to express concern about an FDA proposal to exempt certain biologic products, including biosimilars, from requirements to adhere to U.S. Pharmacopeial (USP) public standards
FDA Policy/General
FDA is planning a consumer survey to update 2002 data on patient experience with and attitudes toward direct-to-consumer (DTC) advertising of drugs and other regulated products. A Federal Register notice says that numerous changes have affected the DTC landscape since 2002, including declines in print readership, the rise
Devices
Beginning next month (9/13), CDRH will allow the use of stand-alone symbols without adjacent text on domestic device labeling, making it consistent with symbols used on devices manufactured for European and other foreign markets. The Center conducted a 7/25 webinar to discuss its final rule on the
Drugs
FDA has awarded a three-year $2 million grant to the Long Island University (LIU) Arnold and Marie Schwartz College of Pharmacy and Health Sciences to study variability in marketed drug products. The research initiative, “Building Towards Statistically-Based Pharmaceutical Quality Standards,” will focus on assessing the variability in some
Devices
Boston Scientific has recalled several lots of its Lotus Valve System due to breaks in the delivery system’s release mechanism, which have resulted in three deaths from catastrophic vessel trauma. “This action is related to potential breakage of the release mandrel on Lotus Valve Systems which were manufactured prior
Drugs
Teva Pharmaceuticals has recalled seven lots of amikacin sulfate injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for glass particulate matter to be present in vials. The product is used short-term for treating serious infections caused by
Drugs
FDA has approved a GSK Consumer Healthcare NDA for Flonase Sensimist Allergy Relief (fluticasone furoate, 27.5 mcg spray) as an over-the-counter treatment for symptoms associated with seasonal and perennial allergies. Previously, the product was approved for prescription-only use. Flonase Sensimist provides non-drowsy, 24-hour relief
Drugs
FDA has granted Novartis a breakthrough therapy designation for LEE011 (ribociclib) and its use in combination with letrozole for treating hormone receptor positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. The designation was based primarily on positive results from the Phase 3 MONALEESA-2 trial,
Drugs
The Alliance for Patient Access says it is concerned that biosimilar labeling may not include relevant clinical trials data submitted by the applicant. Commenting on an FDA draft guidance on labeling for biosimilar products, the alliance says that rather than recognizing the difference between a biosimilar drug and its reference
Devices
Bayer has won a court victory in a product liability case involving its besieged Essure contraceptive device. On 7/26, the federal court in Connecticut ruled on Norman vs Bayer, granting Bayer’s motion to dismiss because the claims were preempted by federal law or failed to provide facts to
Drugs
A 1/18-20 FDA inspection at Xiamen Origin Biotech, Fujian, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API), according to a 7/19 Warning Letter. Specific deviations noted in the letter include: * failing to establish, document, and implement an effective system for
Devices
A 3/7-3/18 FDA inspection at TriMed, Inc., Santa Clarita, CA, found Quality System Regulation violations in the firm’s manufacturing of implantable bone fixation systems and the instruments and drills used to implant the products, according to a just-released Warning Letter from FDA’s Los Angeles