Drugs
FDA has published a guidance, Information Requests and Discipline Review Letters, explaining how the agency will issue and use an information request (IR) and/or a discipline review letter (DRL) during the assessment of an original section 505(j) ANDA. The document does not apply to a supplement or an
Drugs
FDA has published a guidance, Competitive Generic Therapies, describing the process applicants should follow to request the designation of a drug as a competitive generic therapy (CGT) and the criteria for giving a drug that designation. The document also has information on actions the agency may take to expedite the
Drugs
GlaxoSmithKline says the Phase 2 PERLA trial evaluating its dostarlimab (Jemperli) plus chemotherapy versus pembrolizumab (Merck’s Keytruda) plus chemotherapy in first-line patients with metastatic non-squamous, non-small cell lung cancer met its primary endpoint of objective response rate. A company statement says the trial was not designed
Drugs
FDA has denied an Eiger BioPharmaceuticals request for a pre-emergency use authorization (EUA) meeting on its potential application of peginterferon lambda to treat patients with mild-to-moderate Covid-19. A company statement says the agency cited concerns about the conduct of the TOGETHER study and said that any
Drugs
FDA has published a guidance, Post-Complete Response Letter Clarification Teleconference Between FDA and ANDA Applicants Under GDUFA, with recommendations to industry on post-complete response letter (CRL) teleconferences between FDA and ANDA applicants to clarify deficiencies identified in a CRL on a section 505(j) ANDA. The document says
Drugs
Washington Legal Foundation (WLF) says California’s First District Court of Appeals should overturn a trial court ruling that advances a “radical new theory of liability for manufacturers of non-defective prescription drugs.” A WLF statement says the case involves Gilead’s HIV/AIDS drug tenofovir disproxil fumarate (TDF). Although
Biologics
CBER has published four Standard Operating Policies and Procedures (SOPPs) relating to the administrative processing of applications. SOPP 8401: Administrative Processing of Original BLAs and NDAs includes those subject to the Biosimilar User Fee Act (BsUFA) and Prescription Drug User Fee Act (PDUFA). It does not apply to BLAs subject
Drugs
A Bayer citizen petition reiterates the company’s request that FDA confirm that it will stay final approval of an Apotex ANDA for over-the-counter azelastine HCl nasal spray 205.5mcg/spray that cites Bayer’s Astepro Allergy as the reference-listed drug. The 9/29 petition says it
Devices
FDA and researchers from New York University are partnering to design a regulatory science tool (RST) based on data from biomarkers to improve the review processes for stroke rehabilitation devices and determine how best to use them. While there is a growing market of such devices, recommendations for how and
Drugs
As agreed to in the Biosimilar User Fee Act 3 reauthorization, FDA is launching a pilot regulatory science program to further advance biosimilar and interchangeable biological product development. A new program Web site says the pilot will focus on enhancing regulatory decision-making and facilitating science-based recommendations in areas
Drugs
Takeda says it will discontinue manufacturing Natpara (parathyroid hormone) for injection due to manufacturing woes that caused protein particle formation that has led to earlier recalls of the product. The company expects to continue making the product, which is indicated for treating hypoparathyroidism, until the end of next year, and
Drugs
FDA has told Inhibrx that there is potential to pursue an accelerated approval for INBRX-101, an optimized recombinant human AAT-Fc fusion protein, for treating patients with emphysema due to alpha-1 antitrypsin deficiency (AATD). The accelerated pathway would rely on “functional alpha-1 antitrypsin (AAT) serum levels as
Drugs
FDA is establishing a Rare Disease Endpoint Advancement (RDEA) pilot program that it committed to under the PDUFA 7 reauthorization. An agency announcement says the program will support novel efficacy endpoint development for drugs that treat rare diseases. FDA says the RDEA pilot is intended to: * seek to advance rare
Devices
An 11/16/21-1/19/22 FDA inspection at Flawless Beauty and Skin, Ocean, NJ, determined that the firm is an initial importer of several Relumins products. A just-released 8/5 Warning Letter says the products are all legally considered to be medical devices that are intended for
Drugs
A 2/7-2/18 FDA inspection at Sterling Pharmaceutical Services, Dupo, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/27 Warning Letter also says agency review of several product labels determined that the products are legally considered to be unapproved new
Drugs
FDA is launching a pilot of its Split Real Time Application Review (STAR) program that aims to shorten the time from the date of complete submission to the action date. The program was agreed to in the PDUFA 7 commitment letter. An agency announcement says the STAR pilot will apply
Drugs
A Teva Pharmaceutical appeal to the U.S. Supreme of a U.S. Court of Appeals for the Federal Circuit decision in a case involving a so-called “skinny label” for a generic form of GlaxoSmithKline’s (GSK) heart drug Coreg (carvedilol) may be gaining traction now that the high
Devices
FDA says device makers can now send electronic copy (eCopy) or electronic Submission Template And Resource (eSTAR) premarket submissions online through the CDRH Customer Collaboration Portal. The portal is now set up for any device company to register for a portal account to send electronic submissions online. Under the new
Drugs
Researchers from FDA and several academic medical centers say the accelerated approval process has been transformational in precision oncology and has particularly benefited patients with non-small cell lung cancer. Writing in Nature Medicine, the researchers say that since 1992 there have been 42 accelerated approvals in precision oncology for
Devices
FDA has published three guidances describing agency and industry actions on three types of medical device submissions – de novo, 510(k) and PMA – and the effect the actions have on the FDA review clock and goals. The documents cover performance goals negotiated as part of the MDUFA 5 reauthorization. The
Drugs
FDA has granted Calithera Biosciences a fast track designation for mTORC 1/2 inhibitor sapanisertib (CB-228) for treating adult patients with unresectable or metastatic squamous non-small cell lung cancer (sqNSCLC) whose tumors have a mutation in nuclear factor erythroid 2-related factor (NFE2L2, also called NRF2) and who
Drugs
FDA has released a draft guidance entitled “Facility Readiness: Goal Date Decisions Under GDUFA.” Under the new generic drug user fee agreement, which went into effect 10/1, the agency modified its procedures to incorporate facility readiness in review action goal date assignments, according to the document. In cases when