Regulatory & Safety

Canadian CMO Hit with FDA Warning Letter for cGMP Violations

07-Mar-2013 - A Canadian subsidiary of India’s largest CMO (contract manufacturing organization) was cited by the US FDA for failing to investigate rejected batches of product or implement further preventive actions.

Partnership Could Forge Path for Oncology Drug Delivery, Development

07-Mar-2013 - A new partnership between a niche cancer drug discovery company and biotech powerhouse Celgene could pave the way for the future of cancer drug discovery and delivery.

EMA proposes virus testing for food sector-derived trypsin used in drugmaking

06-Mar-2013 - Food industry controls do not ensure porcine trypsin is virus-free according to the EMA, which proposes testing procedures for drugmakers which use the reagent in a new consultation document.

SFDA Aims to Stimulate R&D, Accelerate Approvals and Improve Distribution Practices

05-Mar-2013 - Chinese regulators want to improve how drugs are developed, reviewed and distributed in the country.

People on the Move: Jobs in Pharma

04-Mar-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

FDA Cites API Manufacturer for Stability, Purification Violations

28-Feb-2013 - The US FDA has warned API manufacturer Abbey Color about its inadequate stability program and unreliable water purification system, both of which were cited as earlier violations.

BIO, PhRMA Blast FDA Draft Guidance on E-Subs for Trial Site Data

28-Feb-2013 - Industry groups BIO and PhRMA are airing their discontents about US FDA draft guidance that could force sponsors to submit redundant clinical datasets for each trial site and waste time in critical pre-IND/BLA meetings.

Raman Spectroscopic Device in Fight Against Counterfeit Drugs

27-Feb-2013 - As an FDA commissioned report on counterfeit drugs is released the potential to detect them may lie in a handheld API analyzing device.

Drug Shortages, Lost Business Chief among Concerns on EU API Import Deadline

26-Feb-2013 - US API manufacturers are getting increasingly worried about the looming July 2 deadline to come into compliance with the EU’s new requirements for written GMP certification.

FDA: Risk-based Immunogenicity Testing will Boost Protein Development

25-Feb-2013 - The US FDA says draft guidelines on risk-based immunogenicity testing of protein drugs will encourage the pharma industry to continue development efforts.

People on the Move: Jobs in Pharma

25-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

Cost Increases Likely for API Distributors in Europe Under New GDP Proposals

21-Feb-2013 - European API distributors may see costs increase if guidelines requiring quality systems and ‘management representatives’ at distribution points are adopted.

Dispatches from Informex

Updated IPEC Guide Steers Excipient Manufacturers Away From Unnecessary Tests

21-Feb-2013 - Excipient firms that skip lot testing or use alternative analysis methods should justify their decisions according to a new COA guide issued by IPEC Americas.

People on the Move: Jobs in Pharma

18-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

Hospira’s Manufacturing Woes Continue with US Device Plant 483

14-Feb-2013 - Hospira says bringing medical device manufacturing operations up to code will take 'a lot of work' after Lake Forest, Illinois plant is hit with US FDA Form 483.

FDA Reveals More Info on API File Submissions

13-Feb-2013 - Drug Master File (DMF) completeness reviews required under GDUFA could take three months and should be sought before ANDA submission according to the US Food and Drug Administration (FDA).

News in brief

Sun Takeover Bid Burns Out as Taro Grows

11-Feb-2013 - Sun Pharmaceutical Industries has abandoned its long running efforts to buy Israel’s Taro, explaining the move is in the best interest of shareholders.

ICH Photosafety Guidance Aims to Bridge FDA, EU Differences

11-Feb-2013 - The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation on the photosafety testing of drug compounds.

People on the move: Jobs in Pharma

08-Feb-2013 - In-Pharmatechnologist.com presents its latest round-up of the movers and shakers in the world of pharmaceuticals.

Novo Nordisk Says Warning Letter for Backup Plant Won’t Cause Insulin Shortages

07-Feb-2013 - In its third warning letter released this year for a foreign manufacturer, the FDA has warned Novo Nordisk for failing to follow procedures designed to prevent contamination. But the company downplayed the impact of the letter and said it won’t create any shortages for its US insulin supplies.

SFDA may forge closer ties with Swissmedic

06-Feb-2013 - The SFDA wants to forge closer ties with regulators in Switzerland, to date the only country granted exemption from new EU API import laws.

Quality System Tweaks Necessary to Meet Final Combo Product cGMP Rule

06-Feb-2013 - The US Food and Drug Administration’s (FDA) release of a final rule on cGMP for combo products raises a number of questions as to how drug and device companies will tweak or overhaul their quality systems and which suppliers of products will need to comply, an expert says.

CMOs, CROs will Report Payments to Doctors Under Final 'Sunshine' Rule

05-Feb-2013 - CMOs and CROs must notify sponsors of payments made to physicians on their behalf under long-awaited US 'Sunshine' rules published last week.

Pharma Cargo Theft Down to Lowest Recorded Levels

05-Feb-2013 - The US pharma industry in 2012 saw the lowest number of reported cargo thefts and the lowest average value per incident since the data collection began in 1996.

FDA to Release Long-Awaited Guidance on CMO Agreements, Biosimilars in 2013

04-Feb-2013 - Highly sought-after guidance on quality agreements for contract manufacturing organizations (CMOs) and biosimilar developers is expected in 2013, according to a list of future guidance documents released by the US Food and Drug Administration (FDA).