Drugs
FDA has approved an Allergan supplemental NDA for Avycaz (ceftazidime and avibactam) to include clinical data from two Phase 3 trials in the labeling that supports the indication to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms. In Trial 1, known
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FDA regulatory consulting firm Greenleaf Health has hired recently retired CDER Office on New Drugs (OND) director John Jenkins as principal for drugs and biologics. Jenkins retired last month after almost 25 years at FDA, and nearly 32 years of federal government service. He joined the agency in 1992 as
Drugs
Skadden Arp attorneys have issued a paper analyzing several documents FDA issued in the waning hours of the Obama administration staking out a strong position on its ability to regulate manufacturer communication on off-label uses. “Because the identity of the next FDA commissioner is still unknown,” the paper says,
Drugs
FDA has released the FDA-483 from a 10/5-10/23/15 inspection at CP Pharmaceuticals, Wrexham, UK. The document lists these observations: * failing to establish and follow procedures to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are deficient regarding the system for
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A 1/11-1/19/16 FDA inspection at Facta Farmaceutici, Milan, Italy, found significant violations of current good manufacturing practice regulations in its production of finished pharmaceuticals, according to a 1/13 Warning Letter. Significant violations included: * failing to ensure that laboratory records included complete data derived from all
Drugs
FDA has accepted for review an OptiNose NDA for OPN-375 and its use in treating nasal polyposis in adults. The company expects a user fee review action in September. The submission includes data from more than 1,500 patients and includes two global Phase 3 dose-ranging pivotal efficacy
Drugs
House Energy and Commerce Committee ranking member Frank Pallone, Jr. (D-NJ), Health Subcommittee ranking member Gene Green (D-TX), and Oversight & Investigations Subcommittee ranking member Diana DeGette (D-CO) 1/30 sent a letter to president Trump asking for clarification on FDA’s hiring authority in the wake
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A lengthy online story for Vox questions whether a Silicon Valley approach that reduces or eliminates FDA’s efficacy requirements for new drugs could work. The article says it appears that the Trump administration is using PayPal founder Peter Thiel to help review candidates for the position of FDA commissioner.
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President Donald Trump 1/31 offered assembled pharmaceutical CEOs a deal: We shorten your 15-year new drug development time through a huge reduction in unnecessary FDA regulations on that process, and you repay us with a huge reduction in the prices you charge the American people. To sweeten the
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Merck says that the scope of a draft FDA guidance on the format and content of physiologically based pharmacokinetic (PBPK) analyses should be expanded since such modeling supports sNDAs and sBLAs as well as INDs, NDAs, BLAs, and ANDAs. Also, the letter says, FDA acknowledges that the depth and breadth
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FDA has denied an Acorda Therapeutics petition that asked the agency to “carefully consider the sufficiency of the applicant’s identification and qualification of potentially genotoxic impurities in reviewing an ANDA referencing its Ampyra (dalfampridine) extended release tablets.” The company petition says that certain potentially genotoxic impurities that may be
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FDA has approved two Teva Pharmaceutical Industries NDAs for AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder), both indicated for use in asthma patients. AirDuo is a fixed dose combination product containing the same active ingredients as GlaxoSmithKline’s Advair, indicated for treating
Drugs
FDA has told Regulus Therapeutics that a 6/2016 clinical hold remains in effect and it requested more information on the development program for RG-101, an investigational therapy for treating chronic hepatitis C virus (HCV). The hold was originally placed after the company reported a second serious adverse event
Drugs
While a Twitter blockade ordered by the Trump Administration prevents FDA employees from communicating with the public and industry, agency employees have launched a “parody” Twitter account called @AltFDA to help keep agency information flowing. The rogue Twitter account follows in the pattern of other government agency employees who have
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FDA says its laboratory analysis found inconsistent amounts of belladonna, a toxic substance, in certain homeopathic teething tablets, sometimes far exceeding the amount claimed on the label. The agency is warning consumers that homeopathic teething tablets containing belladonna pose an unnecessary risk to infants and children and urges consumers not
Drugs
FDA has granted AstraZeneca six months pediatric exclusivity for Symbicort (budesonide/formoterol) Inhalation Aerosol, which is currently approved in the U.S. to treat asthma in patients 12 years and older and for the maintenance treatment of chronic obstructive pulmonary disease in adults. The agency’s decision was based on
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A 10/17-10/25/16 FDA inspection at Aurobindo Pharma, Borpatla Village, India, found that equipment cleaning procedures were not adequately validated. A just-released FDA-483 shows the deviation from current good manufacturing practice regulations for active pharmaceutical ingredients.
Drugs
FDA has cleared a DePuy Synthes 510(k) for the Viper and Expedium Fenestrated Screw Systems. When used with the company’s Confidence High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors, the company says. The
Drugs
The CDER Office of Pharmaceutical Quality has issued a Manual of Policies and Procedures (MAPP), Acceptability of Standards from Alternative Compendia (BP/EP/JP), to clarify for reviewers the appropriate use of quality standards for excipients, drug substances, and drug products found in the British, European, and Japanese pharmacopeias. The
Drugs
FDA has approved an Adapt Pharma NDA for Narcan (naloxone) Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory or central nervous system depression. Last year, the agency approved Narcan Nasal Spray 4mg under the expedited review and approval
Drugs
FDA and U.S. Pharmacopeial Convention have announced a 2/27-28 workshop on “Standards for Pharmaceutical Products — Critical Importance of Excipients in Product Development.” Attendees will discuss how the quality and variability of excipients currently impact medicines and how they are expected to impact new technologies such as continuous
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The CDER Small Business and Industry Assistance (SBIA) program says that changes included in the GDUFA 2 agreement now awaiting congressional action address small business concerns that arose under GDUFA 1. In an online SBIA Chronicles, CDER Division of User Fee Management and Budget Formulation generics branch chief Gisa Perez